4330 FIRST AID KIT- 4330 first aid kit

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
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 Antiseptic cleansing of face, hands, and body without soap and water First aid antibiotic first aid to help prevent infection in - minor cuts - scrapes - burns
Authorization status:
unapproved drug other
Authorization number:
0498-0501-00, 0498-0730-01, 0498-4330-01

4330 FIRST AID KIT- 4330 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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4330 First Aid Kit (Neomycin, BZK wipes, FABC- Z019806)

First Aid Burn Cream

Active ingredient

Benzalkonium chloride 0.13%

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

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

Keep out of reach of children

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

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

Stop use and ask a doctor if

irritation, redness or other symptoms develop

the condition persists or gets worse

BZK

Directions

tear open packet and use as a washcloth

BZK

Other information

store at room temperature 15

to 30

C (59

- 86

do not reuse towelette

BZK

Inactive ingredients

water

BZK

Questions

1-800-430-5490

Neomycin

Active ingredient (each gram contains)

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

Ask a doctor before use if you have

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 reach of children

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

Neomycin

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

Neomycin

Other information

store at 15

to 25

C (59

to 77

Neomycin

Inactive ingredient

petrolatum

Neomycin

Questions

1-800-430-5490

4330

Z019806 kit contents

1 NEOMYCIN ANTIBIOTIC 10 PER

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

1 ANTIMCRBL ANTSPTC TWLETTS

1 FIRST AID GUIDE ASHI

1 ABD COMBINE PAD 5" X 9"

1 GZE PADS STERILE 3"X 3" 10'S

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 LBL CONTS 6 3/4"X3 1/2" ID B

1 LABEL COVER, GRAINGER Z019806

1 PR LRG NITRILE GLVES ZIP BAG

1 TAPE ADHESIVE 1 X 2.5 125135

1 KIT, PP 10 UNIT FA

1 TRI BNDG NON WOVEN 40"X40"X56"

1 FIRST AID BURN CREAM 10

First Aid Burn Cream

Principal Display Panel

BZK

Principal Display Panel

Neomycin

Principal Display Panel

4330 Kit Label

Z019806

4330 FIRST AID KIT

4 330 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4330

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4330 -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

10 PACKET

9 g

Pa rt 2

1 PACKET

1.4 mL

Pa rt 3

10 PACKET

9 g

Part 1 of 3

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

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 2 of 3

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

0 9 /18 /20 18

Part 3 of 3

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)

Honeywell Safety Products USA, INC

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

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 -4330 )

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 9 0 3, 0 49 8 -0 730 )

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 50 1)

Revised: 5/2019

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