4390 FIRST AID KIT- 4390 first aid kit 4392 FIRST AID KIT- 4392 first aid kit

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
Eyewash - for flushing the eye to remove loose foreign material, air pollutants or chlorinated water First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns Pain reliever/ fever reducer - temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever First aid antibiotic - first aid to help prevent infection in - minor cuts - scrapes - burns First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes and burns Topical antiseptic Topical anesthetic Topical antiseptic for the temporary relief of pain and itching and helps protect against infection in: - minor cuts and scrapes - burns - sunburn - insect bites - minor skin irritations Antiseptic handwash - for hand washing to decrease bacteria on skin - recommended for repeated use Respiratory stimulant - to prevent or treat fainting temporarily relieves minor aches and pains due to: - headache - muscular aches - minor pain of arthritis - toothache - backache -
Authorization status:
unapproved drug other
Authorization number:
0498-0100-02, 0498-0143-04, 0498-0221-59, 0498-0402-59, 0498-0730-01, 0498-3334-00, 0498-4390-01, 0498-4392-01, 0498-7502-01

4390 FIRST AID KIT- 4390 first aid kit

4392 FIRST AID KIT- 4392 first aid kit

Honeywell Safety Products USA, INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

----------

4390, 4392 First Aid Kit (Neomycin, ammonia inh, alcohol wipes, Burn Sray, Antiseptic Spray,

Hand Sanitizer, aypanal, cedaprin, miralac, sinus decongest, EW- FAK4SHLF-CLSB,

SF00004422)

Eyesaline

Active ingredient

Sterile Water 99%

Eyesaline

Purpose

Eyewash

Eyesaline

Uses

for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyesaline

Warnings

For external use only-

Obtain immediate medical treatment for all open wounds in or near eyes.

To avoid contamination, do not touch tip of container to any surface.

Do not reuse. Once opened, discard.

Do not use

if solution changes color or becomes cloudy

if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

you experience eye pain

changes in vision

continued redness or irritation of the eye

condition worsens or persists

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Eyesaline

Directions

remove contacts before using

twist top to remove

flush the affected area as needed

control rate of flow by pressure on the bottle

if necessary, continue flushing with emergency eyewash or shower

Eyesaline

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline

Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Alcohol Wipe

Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe

Purpose

First aid antiseptic

Alcohol Wipe

Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe

Warnings

For external use only

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burn

When using this product

do not use longer than one week unless directed by a doctor

Stop use and consult a doctor

if condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Alcohol Wipe

Directions

clean the affected area

apply wipe to affected area 1 to 3 times daily

may be covered with a sterile bandage

discard wipe after single use

Alcohol Wipe

Other information

store at room temperature 15

to 25

C (59

to 77

Alcohol Wipe

Inactive ingredient

water

Alcohol Wipe

Questions

1-800-430-5490

Aypanal

Active ingredient

Acetaminophen 325 mg

Aypanal

Purpose

Pain reliever/ fever reducer

Aypanaly

Uses

temporarily relieves minor aches and pains due to the common cold and headache - temporarily

reduces fever

Aypanal

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg in 24 hours, which is the maximum daily amount

child takes more than 5 doses in 24 hours, which is the maximum daily amount

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin rash occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

pain gets worse or lasts more than 10 days in adults

pain gets worse or lasts more than 5 days in children under 12 years

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any

signs or symptoms.

Keep out of reach of children.

Keep out of reach of children.

Aypanal

Directions

do not take more than directed (see overdose warning)

adults and children 12 years of age or older

take two tablets every 4-6 hours while symptoms last

do not take more than 12 tablets in 24 hours

children 6 to under 12 years of age

take 1 tablet every 4-6 hours while symptoms last

do not take more than 5 tablets in 24 hours

children under 6 years consult a doctor

Aypanal

Other information

store at room temperature 15

to 30

C (59

- 86

TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Aypanal

Inactive ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Aypanal

Questions

1-800-430-5490

Neomycin

Active ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin

Purpose

First aid antibiotic

Neomycin

Uses

first aid to help prevent infection in - minor cuts - scrapes - burns

Neomycin

Warnings

For external use only

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

a rash or other allergic reaction develops

you need to use longer than 1 week

Stop use and ask a doctor if

the condition persists or gets worse

a rash or other allergic reaction develops

you need to use longer than 1 week

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Do not use

in the eyes

over large areas of the body

Neomycin

Direction

clean the affected area

apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the

area 1 to 3 times daily

may be covered with a sterile bandage

Neomycin

Other information

store at 15

to 25

C (59

to 77

Neomycin

Inactive ingredient

petrolatum

Neomycin

Questions?

1-800-430-5490

Antiseptic Spray

Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray

Purpose

First aid antiseptic

Antiseptic Spray

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

Antiseptic Spray

Warnings

For external use only

Do not use

in or near the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

the condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Antiseptic Spray

Directions

clean the affected area

spray a small amount of this product on the area 1 to 3 times daily

may be covered with a sterile bandage

if bandaged, let dry first

Antiseptic Spray

Other information

shake well

store at room temperature 15

C (59

Antiseptic Spray

Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene

glycol, propylparaben, trolamine, water

Antiseptic Spray

Questions

1-800-430-5490

Burn Spray

Active ingredient

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray

Purpose

Purpose

Topical antiseptic

Topical anesthetic

Topical antiseptic

Burn Spray

Uses

for the temporary relief of pain and itching and helps protect against infection in:

minor cuts and scrapes

burns

sunburn

insect bites

minor skin irritations

Burn Spray

Warnings

For external use only

Flammable

keep away from fire or flame

contents under pressure

do not puncture or incinerate container

do not expose to temperatures above 120 0 F

Do not use

in or near the eyes or other mucous membranes

in case of serious burns

in case of deep or puncture wounds

for prolonged period of time

on large portion of the body

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days

condition clears up and recurs within a few days

redness, swelling, or irritation occurs

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Burn Spray

Directions

clean the affected area

shake can well before using

hold 4 - 6 inches from surface and spray area until wet

may be covered with a sterile bandage, if bandaged let dry first

for adult institutional use only

not intended for use on children

Burn Spray

Other information

avoid inhaling

use only as directed

intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Burn Spray

Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Hand Sanitizer

Active ingredient

Ethyl alcohol 62%

Hand Santizer

Purpose

Antiseptic handwash

Hand Sanitizer

Uses

for hand washing to decrease bacteria on skin

recommended for repeated use

Hand Sanitizer

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

do not use in the eyes

discontinue use if irritation and redness develops. If condition persists for more than 72 hours

consult a doctor.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer

Directions

wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer

Other information

store at 15

to 25

C (59

to 77

Hand Sanitizer

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate,

fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer

Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

Ammonia

Active ingredient

Ammonia 15%

Ammonia

Purpose

Respiratory stimulant

Ammonia

Uses

to prevent or treat fainting

Ammonia

Warnings

For external use only

Do not use

if you have breathing problems such as asthma or emphysema

Stop use and ask a doctor if

condition persists

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Ammonia

Directions

hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated

on sleeve.

hold near nostrils for inhalation of volatile vapor

Ammonia

Other information

store at room temperature away from light

Ammonia

Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Ammonia

Questions or Comments?

1-800-430-5490

Cedaprin

Active ingredient

Ibuprofen 200 mg (NSAID)

*(nonsteroidal anti-inflammatory drug)

Cedaprin

Purposse

Pain reliever/fever reducer

Cedaprin

Uses

temporarily relieves minor aches and pains due to:

headache

muscular aches

minor pain of arthritis

toothache

backache

the common cold

menstrual cramps

temporarily reduces fever

Cedaprin

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen,

or others]

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Heart attack and stroke warning:

NSAID's, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be

fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer

right before or after heart surgery

Ask a doctor before use if

you have problems or serious side effectsfrom taking pain relievers or fever reducers

stomach bleeding warning applies to you

you have a history of stomach problems such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke

you are taking a diuretic

Ask a doctor or a pharmacist before use if you are

taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirin

under a doctors care for any serious condition

taking any other drug

When using this product,

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

you have symptoms of heart problems or stroke:

chest pain

trouble breathing

weakness in oe part or side of body

slurred speech

leg swelling

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present in the painful area

any new symptoms appea

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3

months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in

the unborn child or complications during delivery.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if

you do not notice any signs or symptoms.

Cedaprin

Directions

do not take more than directed

the smallest effective dose should be used

adult and children 12 years of age and over:

take 1 tablet every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

Cedaprin

Other information

store between 15

C (59

avoid excessive heat and humidity

TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

cedaprin

Inactive ingredients

hypromellose, lactose monohydrate, opadry II 31K, povidone K-30, ferric oxide red, silicon dioxide,

starch, stearic acid, titanium dioxide, triacetin

Cedaprin

Questions or Comments?

1-800-430-5490

Miralac

Active ingredient

Calcium carbonate 420 mg

Miralac

Purpose

Antacid

Miralac

Uses

for the relief of

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

Miralac

Warnings

Ask a doctor before use if you have

kidney stones

calcium-restricted diet

Ask a doctor before use if you are

presently taking a prescription drug. Antacids may interfere with certain prescription drugs

When using this product

do not take more than 12 tablets in a 24- hour period, or use the maximum dosage

Keep out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center

immediately.

Miralac

Directions

chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.

Miralac

Other information

each tablet contains: calcium 170 mg

sucrose free

lactose free

store at room temperature

TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Miralac

Inactive ingredients

magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

Miralac

Questions or Comments

1-800-430-5490

Sinus decongestant

Active ingredient

Phenylephrine HCl 5 mg

Sinus Decongestant

Purpose

Nasal decongestant

Sinus Decongestant

Uses

Temporarily relieves

nasal congestion due to:the common cold, hay fever, or other respiratory allergies

sinus congestion and pressure.

Sinus Decongestant

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the

MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a health

professional before taking this product.

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness

dizziness

sleeplessness occur

symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast feeding

ask a health professional

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately

Sinus Decongestant

Directions

adults and children 12 years of age and over:

take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours

children under 12 years, consult a doctor

Sinus Decongestant

Other information

store at room temperature

Tamper Evident Packets

do not use if open or torn

Sinus Decongestant

Inactive ingredients

colloidal silica, croscarmellose sodium, D and C Red # 27 Lake, dicalcium phosphate, magnesium

stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc

Sinus Decongestant

Questions or Comments

1-800-430-5490

4392

SF00004422 Kit Contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

1 1 X 3 WOVEN 100/BOX

3 NEOMYCIN ANTIBIOTIC 10 PER

1 AMMONIA INHALANTS 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

10 HAND SANITIZER 0.9G WJ BULK

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 COTTON TIPS 100 PER VIAL

1 AYPANAL NON-ASP IND 2/ENV 100

1 CEDAPRIN (IBUPROFEN) 2ENV 100

1 MIRALAC TABS IND PK 2/ENV 100

1 SINUS DECONGESTANT 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 400 EMPTY KIT BLANK

1 POCKET INSERT RED #400 KIT 5R

1 TONGUE BLADES SR WRAPPED 6'S

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

2 x2 PR LRG NITRILE GLVES ZIP BAG

2 WATER-JEL BURN DRESSING 4 X 4

8 CORNER STYROFOAM 3X3X3

2TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

1 RED BIO BAGS 2/BX

Eyesaline

Principal Display Panel

Alcohol Wipe

Principal Display Panel

Aypanal

Principal Display Panel

Neomycin

Principal Display Panel

Antiseptic Spray

Principal Display Panel

Burn Spray

Principal Display Panel

Hand Sanitizer

Principal Display Panel

Ammonia

Principal Display Panel

Cedaprin

Principal Display Panel

Miralac

Principal Display Panel

Sinus Decongestant

Principal Display Panel

4390 Kit Label

FAK4SHLF-CLSB

4390 Kit Contnets

FAK4SHLF-CLSB

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

1 1 X 3 WOVEN 100/BOX

3 NEOMYCIN ANTIBIOTIC 10 PER

1 AMMONIA INHALANTS 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

10 HAND SANITIZER 0.9G WJ BULK

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 COTTON TIPS 100 PER VIAL

1 AYPANAL NON-ASP IND 2/ENV 100

1 CEDAPRIN (IBUPROFEN) 2ENV 100

1 MIRALAC TABS IND PK 2/ENV 100

1 SINUS DECONGESTANT 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 POCKET INSERT RED #400 KIT 5R

1 TONGUE BLADES SR WRAPPED 6'S

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

4 PR LRG NITRILE GLVES ZIP BAG

2 WATER-JEL BURN DRESSING 4 X 4

1 LBL CONTENTS ANSI 2015 CL B

1 LBL CAB CVR ANSI 2015 CL B

2 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

1 RED BIO BAGS 2/BX

4392 Kit Label

SF00004422

4390 FIRST AID KIT

4 390 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -439 0

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -439 0 -0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

118 mL

Pa rt 2

10 POUCH

4 mL

Pa rt 3

50 PACKET

10 0

Pa rt 4

1 BOTTLE, SPRAY

59 mL

Pa rt 5

1 BOTTLE, SPRAY

59 mL

Pa rt 6

30 PACKET

27 g

Pa rt 7

10 PACKAGE

9 mL

Pa rt 8

10 AMPULE

3 mL

Pa rt 9

50 PACKET

10 0

Pa rt

10

50 PACKET

10 0

Pa rt

11

50 PACKET

10 0

Part 1 of 11

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

12/18 /20 18

Part 2 of 11

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 143-0 4

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 3 of 11

AYPANAL NON-ASPIRIN

acetaminophen tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -20 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

c irc le ;U

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 4/10 /20 12

Part 4 of 11

BURN RELIEF

lidocaine hydrochloride spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 221

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

24.6 4 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

O CTO XYNO L-9 (UNII: 7JPC6 Y25QS)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TEA TREE O IL (UNII: VIF56 5UC2G)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 49 8 -0 221-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /18 /20 18

Part 5 of 11

ANTISEPTIC

benzalkonium chloride spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 40 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

O CTO XYNO L 9 (UNII: 7JPC6 Y25QS)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 49 8 -0 40 2-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /18 /20 18

Part 6 of 11

NEOMYCIN

antibiotic ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 730

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN SULFATE

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 730 -0 1

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 3/31/20 10

Part 7 of 11

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 4/15/20 10

Part 8 of 11

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 9 of 11

MIRALAC

calcium carbonate tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 30 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB,

CARBONATE ION - UNII:7UJQ5OPE7D)

CALCIUM

CARBONATE

420 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

white (white)

S core

2 pieces

S hap e

ROUND

S iz e

11mm

Flavor

MINT (mint flavo r)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

0 2/22/20 12

Part 10 of 11

SINUS DECONGESTANT

phenylephrine tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -3331

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SHELLAC (UNII: 46 N10 7B71O)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

red (red)

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 9 /18 /20 18

Part 11 of 11

CEDAPRIN

ibuprofen tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -750 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TRIACETIN (UNII: XHX3C3X6 73)

STARCH, CO RN (UNII: O8 232NY3SJ)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -750 2-0 1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 129

0 1/0 2/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

10 /18 /20 18

4392 FIRST AID KIT

4 392 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -439 2

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -439 2-0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

50 PACKET

10 0

Pa rt 2

1 BOTTLE

118 mL

Pa rt 3

10 POUCH

4 mL

Pa rt 4

50 PACKET

10 0

Pa rt 5

1 BOTTLE, SPRAY

59 mL

Pa rt 6

1 BOTTLE, SPRAY

59 mL

Pa rt 7

30 PACKET

27 g

Pa rt 8

10 PACKAGE

9 mL

Pa rt 9

10 AMPULE

3 mL

Pa rt

10

50 PACKET

10 0

Pa rt

11

50 PACKET

10 0

Part 1 of 11

CEDAPRIN

ibuprofen tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -750 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TRIACETIN (UNII: XHX3C3X6 73)

STARCH, CO RN (UNII: O8 232NY3SJ)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -750 2-0 1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 129

0 1/0 2/20 17

Part 2 of 11

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

12/18 /20 18

Part 3 of 11

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 143-0 4

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 4 of 11

AYPANAL NON-ASPIRIN

acetaminophen tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -20 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

c irc le ;U

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 4/10 /20 12

Part 5 of 11

BURN RELIEF

lidocaine hydrochloride spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 221

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

24.6 4 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

O CTO XYNO L-9 (UNII: 7JPC6 Y25QS)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TEA TREE O IL (UNII: VIF56 5UC2G)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 49 8 -0 221-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /18 /20 18

Part 6 of 11

ANTISEPTIC

benzalkonium chloride spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 40 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

O CTO XYNO L 9 (UNII: 7JPC6 Y25QS)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 49 8 -0 40 2-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /18 /20 18

Part 7 of 11

NEOMYCIN

antibiotic ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 730

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN SULFATE

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 730 -0 1

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 3/31/20 10

Part 8 of 11

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 4/15/20 10

Part 9 of 11

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 10 of 11

MIRALAC

calcium carbonate tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 30 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB,

CARBONATE ION - UNII:7UJQ5OPE7D)

CALCIUM

CARBONATE

420 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

white (white)

S core

2 pieces

S hap e

ROUND

S iz e

11mm

Flavor

MINT (mint flavo r)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

0 2/22/20 12

Part 11 of 11

SINUS DECONGESTANT

phenylephrine tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -3331

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SHELLAC (UNII: 46 N10 7B71O)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

red (red)

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 9 /18 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

10 /18 /20 18

Labeler -

Honeywell Safety Products USA, INC (079287321)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

James Alexander

0 40 756 421

ma nufa c ture (0 49 8 -3334)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, INC

0 79 28 7321

pack(0 49 8 -439 0 , 0 49 8 -439 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultra Seal Co rpo ratio n

0 8 57520 0 4

manufacture(0 49 8 -20 0 1, 0 49 8 -0 30 3, 0 49 8 -3331)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Water-Jel Techno lo gies

15552258 9

manufacture(0 49 8 -0 730 , 0 49 8 -0 40 2, 0 49 8 -0 221, 59 8 9 8 -420 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc.

16 7518 6 17

ma nufa c ture (0 49 8 -0 10 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Changzho u Mao kang Medical

4213170 73

ma nufa c ture (0 49 8 -0 143)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Granules o f India Limited

9 18 6 0 9 236

ma nufa c ture (0 49 8 -750 2)

Honeywell Safety Products USA, INC

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information