4295 FIRST AID KIT- 4295 first aid

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

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
Honeywell Safety Products USA, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
External analgesic - temporarily relieves pain due to minor burns First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in: - minor cuts - scrapes - burns First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water Antiseptic handwash - for hand washing to decrease bacteria on skin - recommended for repeated use
Authorization status:
unapproved drug other
Authorization number:
0498-0203-00, 0498-0501-00, 0498-0750-35, 0498-4295-01, 59898-420-12

4295 FIRST AID KIT- 4295 first aid

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.

----------

4295 First Aid Kit (Triple,Burn Jel, BZK wipe, antiseptic hand gel- SF00002877)

Burn Jel

Active ingredient

Lidocaine HCl 2.0%

Burn Jel

Purpose

External analgesic

Burn Jel

Uses

temporarily relieves pain due to minor burns

Burn Jel

Warnings

For external use only

Do not use

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

When using this product

avoid contact with eyes

Stop use and ask a doctor if

the condition gets worse

symptoms persist 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.

Burn JEl

Directions

adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

children under 2 years of age: ask a doctor

you may report a serious reaction to this product to 800-430-5490

Burn Jel

Other information

store at room temperature - do not use if opened or torn

Burn Jel

Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil,

methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel

Questions

1-800-430-5490

Triple

Active ingredient

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

Triple

Questions?

1-800-430-5490

BZK Wipe

Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe

Purpose

First aid antiseptic

BzK Wipe

Uses

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

BZK Wipe

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 Wipe

Directions

tear open packet and use as a washcloth

BZK Wipe

Other information

store at room temperature 15

to 30

C (59

- 86

do not reuse towelette

BZK Wipe

Inactive ingredient

water

BZK Wipe

Questions

1-800-430-5490

Hand Sanitizer

Active ingredient

Ethyl alcohol 62%

Hand Sanitizer

Purpose

Antiseptic handwash

Hand Sanitizer

Uses

for hand washing to decrease bacteria on skin

recommended for repeated use

Hand Sanitizer

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

do not use in the eyes

discontinue use if irritation and redness develops. If condition persists for more than 72 hours

consult a doctor.

Keep out of reach of children

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

Hand Sanitizer

Directions

wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer

Other information

store at 15

to 25

C (59

to 77

Hand Sanitizer

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate,

fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer

Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

4252

68P2CCU Kit Contents

1 TRIPLE ANTIBIOTIC 10 PER

1 INSTANT COLD PACK 4" X 6"

1 BURN JEL 1/8 OZ, 6 PER

1 POR. CLOTH TAPE 2X10Yd

1 pOR. CLOTH TAPE 1/2X10Y

3 GAUZE CLEAN-WRAP BDGE N/S 4"

1 ABD COMBINE PAD 5" X 9"

1 ABD PADS 8"X10" STERILE

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 ANTISEPTIC WIPES BZK CHL 20'S

1 SCISSOR UTILITY SHEARS 7-1/4"

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

3 PR LRG NITRILE GLVES ZIP BAG

1 ANTISEPTIC HAND GEL 4OZ

1 WATER-JEL BURN DRESSING 4 X 4

1 KIT PP 24 UNIT FA

2 TRI BNDG NON WOVEN 40"X40"X56"

1 EYE PADS STD OVAL STERILE

1 GAUZE PADS 4"X4" 12PLY

5 WOVEN FINGERTIP BANDAGE 3"

10 HEAVY FLEX BANDAGE 7/8" X 3"

5 HEAVY FLEX KNUCKLE BANDAGE

5 HEAVY FLEX LARGE PATCH 2" X 3"

1 ZIP-LOCK BAG 5" X 5" .002

Burn Jel

Principal Display Panel

Triple

Principal Display Panel

BZK Wipe

Principal Display Panel

Hand Sanitizer

Principal Display Panel

4295 Kit Label

SF00002877

4295 FIRST AID KIT

4 295 first aid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -429 5

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -429 5-0 1

1 in 1 KIT

0 9 /13/20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

6 PACKET

21 g

Pa rt 2

10 PACKET

9 g

Pa rt 3

1 PACKET

1.4 mL

Pa rt 4

1 BOTTLE, PLASTIC

118 mL

Part 1 of 4

BURN JEL

gel for burns gel

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 20 3

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

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

TEA TREE O IL (UNII: VIF56 5UC2G)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

CARBO MER HO MO PO LYMER TYPE B ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: HHT0 1ZNK31)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

O CTO XYNO L-9 (UNII: 7JPC6 Y25QS)

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 20 3-0 0

3.5 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 no t final

pa rt348

0 9 /19 /20 18

Part 2 of 4

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 -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 4

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 4 of 4

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

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

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 8 9 8 -420 -

118 mL in 1 BOTTLE, PLASTIC; 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 4/15/20 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

0 9 /13/20 18

Labeler -

Honeywell Safety Products USA, Inc. (079287321)

Registrant -

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 -429 5)

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 20 3, 0 49 8 -0 750 , 59 8 9 8 -420 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Honeywell Safety Products USA, Inc.

Changzho u Mao kang Medical

4213170 73

ma nufa c ture (0 49 8 -0 50 1)

Revised: 4/2019

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