4163 FIRST AID KIT- 4163 first aid kit 4350 FIRST AID KIT- 4350 first aid kit 4375 FIRST AID KIT- 4375 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 - first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
Authorization status:
unapproved drug other
Authorization number:
0498-0121-00, 0498-4163-01, 0498-4350-01, 0498-4375-01

4163 FIRST AID KIT- 4163 first aid kit

4350 FIRST AID KIT- 4350 first aid kit

4375 FIRST AID KIT- 4375 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.

----------

4163, 4350, 4375 First Aid Kit (FABC, PVP wipes- 013055-4444, 018502-4220, Z018502-4220)

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

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

4163

013055-4444 Kit Contents

1 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

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

1 ADH TAPE, .5" X 2.5 YD, 2 PER

1 GAUZE COMP, 1 SQ YARD, 1 PER

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

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

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 KIT STL 10 UN WHITE 01

4350

018502-4220 kit contents

1 TRIANGULAR BDG, NON-STERILE

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

1 GAUZE COMP, 18" X 36", 2 PER

1 TWEEZER PLASTICS 4"

4 O/H PAK,ADH BDG 2"X4", X-LG

1 FIRST AID GUIDE ASHI

10 PVP PREP PADS MEDIUM

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

6 FIRST AID CREAM 1.0GR PKT EACH

2 TAPE ADHESIVE 1/2 X 2.5 125133

1 KIT BAG SOFT PACK SMALL

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 COLD PACK UNIT 4"X6" BULK

4 WOVEN FINGERTIP BANDAGE 2"

4 WOVEN KNUCKLE BANDAGE

4375

Z018502-4220

1 TRIANGULAR BDG, NON-STERILE

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

1 GAUZE COMP, 18" X 36", 2 PER

1 TWEEZER PLASTICS 4"

4 O/H PAK,ADH BDG 2"X4", X-LG

1 FIRST AID GUIDE ASHI

10 PVP PREP PADS MEDIUM

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

6 FIRST AID CREAM 1.0GR PKT EACH

2 TAPE ADHESIVE 1/2 X 2.5 125133

1 KIT BAG SOFT PACK SMALL

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 COLD PACK UNIT 4"X6" BULK

4 WOVEN FINGERTIP BANDAGE 2"

4 WOVEN KNUCKLE BANDAGE

First Aid Burn Cream

Principal Display Panel

Povidone Iodine Swab

Principal Display Panel

4163 Kit Label

013055-4444

4350 Kit Label

018502-4220

4375 Kit Label

Z018502-4220

4163 FIRST AID KIT

4 163 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -416 3

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -416 3-0 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

6 PACKET

5.4 g

Pa rt 2

10 POUCH

3 mL

Part 1 of 2

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 2

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

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

4350 FIRST AID KIT

4 350 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4350

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4350 -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

6 PACKET

5.4 g

Pa rt 2

10 POUCH

3 mL

Part 1 of 2

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 2

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

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

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

4375 FIRST AID KIT

4 375 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4375

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4375-0 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

6 PACKET

5.4 g

Pa rt 2

10 POUCH

3 mL

Part 1 of 2

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 2

PVP IODINE WIPE

povidone-iodine 10% swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 121

Honeywell Safety Products USA, INC

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

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

pack(0 49 8 -416 3, 0 49 8 -4350 , 0 49 8 -4375)

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

Sio n Bio text Medical

53277519 4

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

Revised: 6/2019

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