4213 FIRST AID KIT- 4213 first aid kit

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

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antiseptic - first aid to help prevent the risk of infection in minor cuts, scrapes, and burns First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes and burns Respiratory stimulant - to prevent or treat fainting Pain reliever/fever reducer temporarily reduces fever and relieves minor aches and pains associated with: - a cold - headache - toothache - muscular aches - backache - minor pain of arthritis - premenstrual and menstrual periods
Authorization status:
unapproved drug other
Authorization number:
0498-0114-01, 0498-0121-00, 0498-0143-04, 0498-0402-59, 0498-3334-00, 0498-4213-01

4213 FIRST AID KIT- 4213 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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4213 First Aid Kit (PVP wipes, alcohol wipes, Antiseptic Spray, ASA, ammonia- 340410F)

Povidone Iodine Swab

Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

Povidone Iodine Swab

Purpose

First aid antiseptic

Povidone Iodine Swab

Uses

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

Povidone Iodine Swab

Warnings

For external use only

Do not use

over large areas of the body

on individuals who are allergic or sensitive to iodine

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 wek unless directed by a doctor

Stop use and ask a doctor if

conditions persists or gets worse

irritation and redness develops

Keep out of reach of children

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

Povidone Iodine Swab

Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate

tip and apply solution to injury.

clean affected area

apply to affected area 1 to 3 times daily

may be covered with a sterile bandage

discard swab after single use

Povidone Iodine Swab

Other information

store at room temperature away from light

keep from freezing or excessive heat

do not use if package is torn or open

Povidone Iodine Swab

Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

Povidone Iodine Swab

Questions and comments

1-800-430-5490

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

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

Ammonia Inhalant

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

1-800-430-5490

Aspirin

Active Ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Aspirin

Purpose

Pain reliever/fever reducer

Aspirin

Uses

temporarily reduces fever and relieves minor aches and pains associated with:

a cold

headache

toothache

muscular aches

backache

minor pain of arthritis

premenstrual and menstrual periods

Aspirin

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

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

if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

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 or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

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

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

ringing in the ears or loss of hearing occurs

any new symptoms appear

If pregnant or breast-feeding,

If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use

aspirin during the last three 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.

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

Aspirin

Directions

drink a full glass of water with each dose

adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last,

not more than 12 tablets in 24 hours

children under 12 years of age: consult a doctor

Aspirin

Other information

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

TAMPER EVIDIENT PACKETS - DO NOT USE IF OPEN OR TORN

Aspirin

Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*,

polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

*may contain these ingredients

Aspirin

Questions or Comments?

1-800-430-5490

Povidone Iodine Swab

Principal Display Panel

Alcohol

Principal Display Panel

Antiseptic Spray

Principal Display Panel

Ammonia

Principal Display Panel

Aspirin

Principal Display Panel

4213 Kit Label

340410F

4213 Kit Contnets

340410F

1 INSTANT COLD PACK 4" X 6"

1 PVP IODINE WIPES 10 PER

1 ADH TAPE W/P 1/2"X 2 1/2 YD

1 FIRST AID GUIDE ASHI

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 FIRST AID SPRAY AEROSOL 3 OZ

1 ASPIRIN 5 GR BTL OF 100'S

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

4 WIPE ALCOHOL PREP IPA 70% (DUKAL)

1 KIT STL 10 UN WHITE 01

4 NON ADHERENT PAD 2" X 3"

2 AMMONIA INHALANT, BULK

4213 FIRST AID KIT

4 213 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4213

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4213-0 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

4 POUCH

1.6 mL

Pa rt 2

10 POUCH

3 mL

Pa rt 3

1 BOTTLE, SPRAY

59 mL

Pa rt 4

2 AMPULE

0 .6 mL

Pa rt 5

50 PACKET

10 0

Part 1 of 5

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 2 of 5

PVP IODINE WIPE

povidone-iodine 10% swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 121

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 121-0 0

0 .3 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

unappro ved drug o ther

0 9 /18 /20 18

Part 3 of 5

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 4 of 5

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 5 of 5

ASPIRIN

aspirin tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 114

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ASPIRIN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

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

MINERAL O IL (UNII: T5L8 T28 FGP)

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SE 2 2 0 8 ( 10 0 MPA.S) (UNII: B1QE5P712K)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

FR21

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 114-0 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 9 /19 /20 18

Honeywell Safety Products USA, INC

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 -4213)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultra Seal Co rpo ratio n

0 8 57520 0 4

ma nufa c ture (0 49 8 -0 114)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Water-Jel Techno lo gies

15552258 9

ma nufa c ture (0 49 8 -0 40 2)

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

Sio n Bio text Medical

53277519 4

ma nufa c ture (0 49 8 -0 121)

Revised: 3/2019

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