4219 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 First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in - minor cuts - scrapes - burns Antiseptic-Topical pain relief - prevent infection in minor scrapes, and temporary relief of itching of insect bites Anti-itch cream - for the temporary relief of itching associated with minor skin irritations and rashes
Authorization status:
unapproved drug other
Authorization number:
0498-0100-01, 0498-0733-00, 0498-0750-35, 0498-0800-35, 0498-0801-35, 0498-4219-01

4219 FIRST AID KIT- 4219 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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4219 First Aid Kit (EW, triple, HC cr, Sting relief- 013061-4454)

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

Triple

Active ingredient (each gram contains)

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

F) tamper evident sealed packets - do not use if packet is torn or

opened

Triple

Inactive ingredient

petrolatum

Triple

Questions

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

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

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

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

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

Hydrocortisone Cream

Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone

Purpose

Anti-itch cream

Hydrocortisone

Uses

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

Hysrocortisone

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 ..

Hydrocortisone

Questions or Comments?

1-800-430-5490

4219

013061-4454 Kit Contents

1 FNGRTIP-5 PER, KNCKL BDG-4 PER

1 TRIPLE ANTIBIOTIC 10 PER

1 TRIANGULAR BDG, NON-STERILE

1 BANDAGE COMP, 3" OFFSET, 2 PER

1 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 1 OZ EYE WASH W/PADS & STRIPS

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

1 NITRILE GLOVES 2PR BBP

1 CPR MICROSHIELD W/2 PR LTX GLV

1 BBP PROTECT APPAREL KIT

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 LABEL RAPID BLANK 24U/50P

1 KIT STL 24 UN WHITE 01

1 STING RELIEF 10

Eyewash

Principal Display Panel

Triple

Principal Display Panel

Sting Relief

Principal Display Panel

Hydrocortisone

Principal Display Panel

4219 Kit Label

013061-4454

4219 FIRST AID KIT

4 219 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4219

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4219 -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

30 mL

Pa rt 2

10 PACKET

9 g

Pa rt 3

10 POUCH

4 mL

Pa rt 4

10 PACKET

9 g

Pa rt 5

10 PACKET

9 g

Part 1 of 5

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 2 of 5

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

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

BACITRACIN

40 0 [iU] in 1 g

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

POLYMYXIN B

50 0 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 -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 final

pa rt333B

0 9 /19 /20 18

Part 3 of 5

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

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

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

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

MENTHO L (UNII: L7T10 EIP3A)

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 4 of 5

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

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

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

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 5 of 5

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

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

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

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

Ho neywell Safety Pro ducts USA, INC

0 79 28 7321

pa c k(0 49 8 -4219 )

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

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

Safetec o f America Inc

8 749 6 526 2

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

Honeywell Safety Products USA, INC

Revised: 10/2019

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