4248 FIRST AID KIT kit

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

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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 Respiratory stimulant - to prevent or treat fainting Topical antiseptic Topical anesthetic for temporary relief of pain and itching and helps protect against infection in - minor cuts and scrapes - insect bites - minor skin irritations Topical antiseptic Topical anesthetic Topical anesthetic 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 First aid antibiotic First aid antibiotic 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 Antacid for the relief of - acid indigestion - heartburn - sour stomach - upset stomach associated with these symptoms First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water Pain reliever/fever redu
Authorization status:
unapproved drug other
Authorization number:
0498-0021-40, 0498-0031-40, 0498-0100-02, 0498-0143-04, 0498-0501-00, 0498-0733-00, 0498-0750-36, 0498-0800-35, 0498-0801-35, 0498-2422-01, 0498-3334-00, 0498-4248-01

4248 FIRST AID KIT- 4248 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.

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4248 First Aid Kit (Ammon, BZK , 1st aid Spray WS, alcohol wipe, Aypanal, Miralac, Burn Sp

WS, Triple, EW, HC cr,, Pain stopper, sting relief, sinus decongest, tetrasine, cold spray-

68600PROAM )

Eyewash

Active ingredient

Sterile Water 99%

Eyewash

Purpose

Eyewash

Eyewash

Uses

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

Eyewash

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.

Eyewash

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

Eyewash

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash

Questions

1-800-430-5490

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 ingredient

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

Ammonia

Questions or Comments?

1-800-430-5490

Water Soluble 1st Aid Spray

Active ingredient

Benzethonium chloride 0.2% w/w - Benzocaine 10% w/w

Water Soluble 1st Aid Spray

Purpose

Topical antiseptic

Topical anesthetic

Water Soluble 1st Aid Spray

Uses

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

minor cuts and scrapes

insect bites

minor skin irritations

Water Soluble 1st Aid 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 temperature above 120 0 F

Do not use

in the eyes or other mucous membranes

in cases of serious burns

in case of deep orpuncture wounds

for a 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 occurs again within a few days

redness, swelling, or irritation occurs

Keep out of reach of children

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

Water Soluble 1st Aid 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

Water Soluble 1st Aid Spray

Other information

avoid inhaling

use only as directed

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

Water Soluble 1st Aid Spray

Inactive ingredients

dipropylene glycol, isobutane, N-butane, propane

Burn Relief Water Soluble

Active ingredients

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Relief Water Soluble

Purpose

Topical antiseptic

Topical anesthetic

Topical anesthetic

Burn Relief Water Soluble

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 Relief Water Soluble

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 Relief Water Soluble

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 Relief Water Soluble

Other information

avoid inhaling

use only as directed

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

Burn Relief Water Soluble

Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Triple

Active ingredients

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Triple

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple

Uses

first aid to help prevent infection in

minor cuts

scrapes

burns

Triple

Warnings

For external use only

Allergy alert do not use if you are allergic to any of the ingredients

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

a deep or puncture wounds

animal bites

serious burns

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 the reach of children

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

Triple

Directions

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

Triple

Other information

store at 15

to 25

C (59

to 77

tamper evident sealed packets

do not use if packet is torn or opened

Triple

Inactive ingredient

petrolatum

Alcohol

Active ingredient

Isopropyl alcohol 70%

Alcohol

Purpose

First aid antiseptic

Alcohol

Uses

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

Alcohol

Warnings

For external use only

Flammable, keep away from fire or flame.

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

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

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

Other information

store at room temperature 15

to 25

C (59

to 77

Alcohol

Inactive ingredient

water

Miralac

Active ingredient (in each chewable tablet)

Miralac

Purpose

Antacid

Miralac

Uses

for the relief of

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

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 of this product for

more than 2 weeks, except under the advice and supervision of a doctor.

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

BZK

Active ingredient

Benzalkonium chloride 0.13% w/v

BZK

Purpose

First aid antiseptic

BZK

Uses

Antiseptic cleansing of face, hands, and body without soap and water

BZK

Warnings

For external use only

Do not use

in the eyes or over large areas of the body

on mucous membranes

on irritated skin

in case of deep puncture wounds, animal bites or serious burns, consult a doctor

longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

if irritation, redness or other symptoms develop

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

BZK

Directions

tear open packet and use as a washcloth

BZK

Other information

store at room temperature 15

to 30

C (5

- 86

do not reuse towelette

BZK

Inactiave ingredient

water

BzK

Questions

1-800-430-5490

Aypanal

Active ingredient

Acetaminophen 500 mg

Aypanal

Purpose

Pain reliever/fever reducer

Aypanal

Uses

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

temporarily reduces fever

Ask a doctor before use if you have

liver disease

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.

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 skin reaction 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 or pharmacist before use if

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

Overdose warning: In case ofl 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.

Aypanal

Directions

do not take more than directed (see overdose warning)

adults and children 12 years of age and over: Take 2 tablets with water every 6 hours while

symptoms last.

do not take any more than 8 tablets in 24 hours.

children under 12: consult a doctor

Aypanal

Other information

store at room temperature 15

C (59

TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN

Aypanal

Inactive igredients

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

Aypanal

Questions or Comments

1-800-430-5490

Hydrocortisone

Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hyrdocortisone

Purpose

Anti-itch cream

Hydrocortisone

Uses

for the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone

Warnings

For external use only

Ask a doctor before use if

you are using any other hydrocortisone product

When using the product

avoid contact with eyes

do not begin use of any other hydrocortisone product unless you have consulted a doctor

do not use for the treatment of diaper rash

Stop use and ask a doctor if

condition worsens

condition persists for more than 7 days

condition clears up and recurs within a few days

Keep out of reach of children

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

Hydrocortisone

Directions

adults and children 2 years and older:

clean the affected area

apply to the area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Hydrocortisone

Other information

store at room temperature (do not freeze)

Hydrocortisone

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate,

methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water,

stearic acid, trolamine

Hydrocortisone

Questions or Comments?

1-800-430-5490

Sting Relief

Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief

Purpose

Antiseptic

Topical pain relief

Sting Relief

Uses

prevent infection in minor scrapes, and temporary relief of itching of insect bites

Stop use and ask a doctor

if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Sting Relief

Warnings

For external use only

Flammable, keep away from open fire or flame

Do not use

over large areas of the body

in eyes

over raw or blistered areas

Keep out of reach of children.

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

Sting Relief

Directions

adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.

children under 2 years of age: consult a doctor.

Sting Relief

Inactive ingredients

benzalkonium chloride, menthol, and purified water

Questions or Comments?

1-800-430-5490

Pain Stopper

Active ingredient (in each tablet)

Acetaminophen 110mg

Aspirin 162mg (NSAID)*

Caffeine 32.4mg

Salicylamide 152mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Stopper

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Diuretic

Pain reliever/fever reducer

Pain Stopper

Uses

for the temporary relief of minor aches and pains due to:

common cold

headache

muscular aches

premenstrual and menstrual cramps

Pain Stopper

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this product. When using this product, if changes in behavior with nausea and

vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a

rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

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

skin reddening

blisters

rash

rash

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

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

more than 12 tablets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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

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

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you are taking a diuretic

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Stop using and ask a doctor if

symptoms do not improve

new symptoms occur

pain or fever persists or gets worse

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pin that does not get better

if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this

product.

If pregnant or breast-feeding

ask a healthcare professional before use.

It is especially important not to use aspirin 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

pregnancy.

KEEP OUT OF REACH OF CHILDREN.

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 children even if you do not

notice any signs or symptoms.

Pain Stopper

Directions

adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist

do not take more than 12 tablets in 24 hours

children under 12 years: consult a doctor

Pain Stopper

Other information

store at a controlled room temperature 15

C (59

TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN

Pain Stopper

Inactive ingredients

FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,

Pain Stopper

Questions or Comments?

1-800-430-5490

Sinus Decongestant

Active ingredient (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Sinus Decongestant

Purpose

Pain relieve/fever reducer

Nasal decongestant

Sinus Decongestant

Uses

temporarily relieves these symptoms associated with hayfever and other upper respiratory allergies

headache

sinus congestion and pressure

nasal congestion

minor aches and pains

helps decongest sinus openings and passages

Sinus Decongestant

Warnings

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

if you take more than 4,00 mg acetaminophen in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

with other drugs containing acetaminophen

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 skin reaction occurs, stop use and seek medical attention right away.

Do not use

with any other product containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you are now taking a prescription monoamine oxidase inhibiter (MAOI) (certain drugs for

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

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before use.

Ask a doctor before use if you have

heart disease

high blood pressure

diabetes

thyroid disease

difficulty in urination due to enlargement of the prostate gland

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur

pain or nasl congestion get worse or last more than 7 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children.

Overdose warning: In case of accidental overdose, getmedical help or contact a Poison Control Center

right away. Promt medical attention is critical for adults as well as children even if you do not notice

any signs or symptoms.

Sinus Decongestant

Directions

do not take more than directed (see overdose warning)

Adults and children 12 years of age and older: take 2 tablets every 4-6 hours while symptoms persist

do not exceed 8 tablets in 24 hours unless directed by a doctor

Children under 12 years: consult a doctor

Sinus Decongestant

Other information

store at room temperature 15-30C (59-86F)

avoid excessive heat and humidity

TAMPER EVIDENT PACKETS - DO NOT USE IF OPEN OR TORN

Sinus Deacongestant

Inactive ingredients

FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Sinus Decongestant

Questions or Comments?

1-800-430-5490

Tetrahydrozoline HCL

Active ingredient

Tetrahydrozoline HCl 0.05%

Tetrahydrozoline HCL

Purpose

Redness reliever

Tetrahydroziline HCL

Uses

relieves redness of the eye due to minor eye irritations

Tetrahydrozoline HCL

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use if

you have narrow angle glaucoma

When using this product

pupils may become enlarged temporarily

overuse may produce increased redness of the eye

remove contact lenses before using

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

replace cap after using

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye

the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Tetrahydrozoline HCL

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Tetrahydrozoline HCL

Other information

Store at 15° to 30°C (59° to 86°F)

Tamper evident. Do not use this product if imprinted neckband is missing or broken.

RETAIN THIS CARTON FOR FUTURE REFERENCE

Distributed by

North by Honeywell

900 Douglas Pike

Smithfield, RI 02917

Tetrahydrozoline HCL

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

4248

68600PROAM KIT CONTENTS

1 1X3 PLASTIC 100/BOX

1 WOVEN 2" X 3" 25/BOX

1 FINGERTIP 8 WOVEN 25/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 BUTTERFLY CLOS MED 100/BX DS

1 SWIFT KNUCKLE 40/BX

1 1 X 3 WOVEN 100/BOX

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 GAUZE BANDAGE, 4" X 6 YD

1 INSTANT COLD PACK 4" X 6"

1 HYDROCORTISON,1.O%,1/32 OZ,10P

1 ELASTIC TAPE 1" X 5YD

1 O/H TAPE ADHESIVE TRI-CUT

2 GAUZE BANDAGE 1" x 2 YDS

2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ

2 GAUZE BANDAGE 4"X2 YDS STRETCH GZ

1 FIRST AID GUIDE ASHI

2 BLOODSTOPPER

1 NON ADHERENT PADS 2"X3" 50'S

1 ABD COMBINE PAD 5" X 9"

1 GZE PADS STERILE 4"X 4" 25'S

1 CO-FLEX BANDAGE 2"X 5YDS TAN

1 CPR FILTERSHIELD 77-100

1 COTTON TIPS 100 PER VIAL

1 ANTISEPTIC WIPES BZK CHL 20'S

1 FIRST AID SPRAY AEROSOL 3 OZ

1 ALCOHOL WIPES 50'S

1 AYPANAL NON-ASP IND 2/ENV 250

1 PAIN STOPPERS IND PK 2ENV 250

1 MIRALAC TABS IND PK 2/ENV 250

1 BURN SPRAY 3 OZ

1 SINUS DECONGESTANT 2/ENV 100

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 HYDROCORTISONE 1% .9 GRM 20'S

1 TETRASINE EYE DROPS 1/2 OZ

2 HAND & SKIN LOTION 1GM 20/BX

1 SWIFT-STAT BLOOD CLOTTER 3 OZ

1 COLD SPRAY 4 OZ

1 POISON OAK/IVY CLEANSER 4 OZ

1 COLD PACK 5"X9" BOXED

2 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SPLINTER FORCEP 4 1/2"

1 SCISSOR LISTER BDG S/S 5 1/2"

1 POCKET INSERT RED #600 KIT

1 600 EMPTY KIT BLANK

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 2 PR LRG NITRILE GLVES ZIP BAG

6 WATER-JEL BURN DRESSING 2 X 6

6 WATER-JEL BURN DRESSING 2 X 2

2 TRI BNDG NON WOVEN 40"X40"X56"

1 STING Relief SWAB 10

1 RED BIO BAGS 2/BX

Eyewash

Principal Display Panel

Ammonia

Principal Display Panel

Water Soluble 1st Aid Spray

Principal Display Panel

Burn Relief Water Soluble

Principal Display Panel

Triple

Principal Display Panel

Alcohol

Principal Display Panel

Miralac

Principal Display Panel

BZK

Principal Display Panel

Aypanal

Principal Display Panel

Hydrocortisone

Principal Display Panel

Sting Relief

Principal Display Panel

Pain Stopper

Principal Display Panel

Sinus Decongestant

Principal Display Panel

Tetrahydrozoline HCL

Principal Display Panel

4248 Kit Label

68600PROAM

4248 FIRST AID KIT

4 24 8 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4248

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4248 -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

2 BOTTLE

236 mL

Pa rt 2

10 AMPULE

3 mL

Pa rt 3

1 CAN

8 5 g

Pa rt 4

1 CAN

8 5 g

Pa rt 5

20 PACKET

10 g

Pa rt 6

50 POUCH

20 mL

Pa rt 7

125 PACKET

Pa rt 8

20 PACKET

28 mL

Pa rt 9

125 PACKET

Pa rt

10

30 PACKET

27 g

Pa rt

11

10 POUCH

4 mL

Pa rt

12

125 PACKET

Pa rt

13

50 PACKET

10 0

Pa rt

14

1 BOTTLE, DROPPER

15 mL

Pa rt

15

30 PACKET

27 g

Part 1 of 15

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, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

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 15

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 3 of 15

FIRST AID ANTISEPTIC WATER SOLUBLE

benzethonium chloride, benzocaine spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 0 31

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

0 .2 g

in 10 0 g

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

10 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ISO BUTANE (UNII: BXR49 TP6 11)

BUTANE (UNII: 6 LV4FOR43R)

PRO PANE (UNII: T75W9 9 11L6 )

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 0 31-40

8 5 g in 1 CAN; 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 9 /19 /20 18

Part 4 of 15

BURN WATER SOLUBLE

benzocaine, benzethonium chloride, menthol spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 0 21

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

0 .2 g in 10 0 g

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

10 g in 10 0 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .33 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ISO BUTANE (UNII: BXR49 TP6 11)

BUTANE (UNII: 6 LV4FOR43R)

PRO PANE (UNII: T75W9 9 11L6 )

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 0 21-40

8 5 g in 1 CAN; 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 rt348

11/12/20 18

Part 5 of 15

TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 750

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [iU] in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [iU] in 1 g

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

NEOMYCIN

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 750 -36

0 .5 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 9 /19 /20 18

Part 6 of 15

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 7 of 15

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

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

11mm

Flavor

MINT

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

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 8 of 15

ANTISEPTIC TOWELETTE

benzalkonium chloride liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 50 1

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

1.3 mg

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 50 1-0 0

1.4 mL 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 rt333E

12/22/20 17

Part 9 of 15

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 10 of 15

HYDROCORTISONE

anti-itch cream ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

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

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 8 0 0 -35

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 no t final

pa rt348

0 3/0 6 /20 13

10 /15/20 19

Part 11 of 15

STING RELIEF PAD

ethyl alcohol, lidocaine swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 733

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

20 mg

in 1 mL

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

ALCOHOL

0 .5 mL

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MENTHO L (UNII: L7T10 EIP3A)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 733-0 0

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 rt348

12/23/20 17

Part 12 of 15

PAIN STOPPERS

acetaminophen, caffeine, aspirin, salicylamide tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -2422

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

110 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

32.4 mg

SALICYLAMIDE (UNII: EM8 BM710 ZC) (SALICYLAMIDE - UNII:EM8 BM710 ZC)

SALICYLAMIDE

152 mg

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

16 2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PO VIDO NE K3 0 (UNII: U725QWY32X)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

o range (BRIGHT ORANGE)

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

FR;2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -2422-0 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

OTC mo no graph no t final

pa rt343

0 1/0 2/20 17

Part 13 of 15

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SHELLAC (UNII: 46 N10 7B71O)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

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

TALC (UNII: 7SEV7J4R1U)

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

Product Characteristics

Color

re d

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 14 of 15

EYE DROPS

tetrahydrozoline hydrochloride solution/ drops

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 16 1

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TETRAHYDRO ZO LINE HYDRO CHLO RIDE (UNII: 0 YZT43HS7D)

(TETRAHYDROZOLINE - UNII:S9 U0 25Y0 77)

TETRAHYDROZOLINE

HYDROCHLORIDE

0 .0 5 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

BO RIC ACID (UNII: R57ZHV8 5D4)

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

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End Date

1

15 mL in 1 BOTTLE, DROPPER; 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 final

pa rt349

0 7/0 4/20 18

Part 15 of 15

HYDROCORTISONE

anti-itch cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

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

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 8 0 1-35

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 no t final

pa rt348

10 /15/20 19

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

pa c k(0 49 8 -4248 )

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 -2422, 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

Dixo n Investments

1153158 22

manufacture(0 49 8 -0 0 31, 0 49 8 -0 0 21)

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 8 0 0 , 0 49 8 -0 8 0 1, 0 49 8 -0 750 )

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

KC PharmaceuticLS, INC.

174450 46 0

ma nufa c ture (0 49 8 -0 16 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Changzho u Mao kang Medical

4213170 73

manufacture(0 49 8 -0 143, 0 49 8 -0 50 1)

Honeywell Safety Products USA, INC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Safetec o f America Inc

8 749 6 526 2

ma nufa c ture (0 49 8 -0 733)

Revised: 10/2019

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