4189 FIRST AID KIT- 4189 first aid kit

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

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Active ingredient:
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antiseptic External analgesic - prevent skin infection - for temporary relief of pain associated with minor burns First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns Respiratory stimulant - to prevent or treat fainting Eyewash - for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
Authorization status:
unapproved drug other
Authorization number:
0498-0100-01, 0498-0143-04, 0498-0903-34, 0498-3334-00, 0498-4189-01

4189 FIRST AID KIT- 4189 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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4189 First Aid Kit (FABC, Amm Inh, EW, alcohol wipes- 010742-3236)

First Aid Burn Cream

Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream

Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream

Uses

prevent skin infection

for temporary relief of pain associated with minor burns

First Aid Burn Cream

Warnings

For external use only

Do not use

in or near the eyes

if you are allergic to any of the ingredients

in large areas of the body, particularly over raw surfaces or blistered areas

for more than 10 days

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days or clear up and occurs again within a few days

First Aid Burn Cream

Directions

adults and children 2 years of age and older:

clean the affected area

apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected

area 1 to 3 times daily

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

First Aid Burn Cream

Other information

tamper evident sealed packets

do not use if packet is opened or torn

First Aid Burn Cream

Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate

SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine,

water

First Aid Burn Cream

Questions

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

Ammonia Inhalent

Active ingredient (in each ampule)

Ammonia 15%

Ammonia Inhalent

Purpose

Respiratory stimulant

Ammonia Inhalent

Uses

to prevent or treat fainting

Ammonia Inhalent

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 Inhalent

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 Inhalent

Other information

store at room temperature away from light

Ammonia Inhalent

Inactive ingredients

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

Ammonia Inhalent

Questions

1-800-430-5490

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

4189

010742-3236 Kit Contents

1 FIRST AID BURN CREAM 6 PER

2 AMMONIA INHALANTS 10 PER

1 TRIANGULAR BDG, NON-STERILE

2 GAUZE PADS, 3" X 3", 4 PER

1 FORCEPS & SCISSORS, 1 EA

1 GAUZE BANDAGE, 2" X 6 YD,2 PER

1 BUFFERED EYE WASH 1 OZ BTL

4 ADH BDG,PLSTIC,3/4"X3",16 PER

1 ALCOHOL PREP PADS 10P

1 ADHESIVE TAPE W/P 1/2"X 5 YD

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 16 UN (VERTICAL)

1 LABL INSTR FA REV A

First Aid Burn Cream

Principal Display Panel

Alcohol Wipe

Principal Display Panel

Ammonia Inahalent

Principal Display Panel

Eyewash

Principal Display Panel

4189 Kit Label

010742-3236

4189 FIRST AID KIT

4 189 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -418 9

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -418 9 -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

20 AMPULE

6 mL

Pa rt 2

6 PACKET

5.4 g

Pa rt 3

1 BOTTLE

30 mL

Pa rt 4

10 POUCH

4 mL

Part 1 of 4

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 2 of 4

FIRST AID BURN

benzalkonium chloride, lidocaine hydrochloride cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 9 0 3

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 g

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

HYDROCHLORIDE

0 .5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

WATER (UNII: 0 59 QF0 KO0 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

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

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 9 0 3-34

10 in 1 BOTTLE, UNIT-DOSE

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 no t final

pa rt333A

12/20 /20 17

Part 3 of 4

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 1

30 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 4 of 4

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

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 -418 9 )

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 9 0 3)

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

Honeywell Safety Products USA, INC

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)

Revised: 3/2019

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