4007 FIRST AID KIT kit 4013 FIRST AID KIT kit

4013 First Aid Kit by

Drug Labeling and Warnings

4013 First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Burn Jel 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

Paws Active ingredient

Ethyl alcohol 66.5%

Paws Purpose

Antiseptic

Paws Uses

• for handwashing to decrease bacteria on skin when soap and water is not available

Paws Warnings

For external use only

Flammable: keep away from fire or flame

Do not use

• in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if

• irritation or redness develop and persist for more than 72 hours

Keep out of reach of children

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

Paws Directions

• wet hands and wrists thoroughly for 15 seconds and allow to air dry
• always reseal after use
• children under 6 years of age should be supervised when using this product

Paws Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Paws Questions

1-800-430-5490

4007 34TP165 Kit Contents

1 1 X 3 PLASTIC 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 TRIANGULAR BDG, NON-STERILE

1 INSTANT COLD PACK 4" X 6"

1 BURN JEL 1/8 OZ, 6 PER

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

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 F. A. INST CHART SM (INDIVIDUAL LBL)

1 CPR KIT-MASK, GLOVES, WIPES

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 BODY FLUID CLEAN UP KIT BAG

1 KIT PP 24 UNIT FA

4013 34T150 kit contents

1 1 X 3 PLASTIC 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 TRIANGULAR BDG, NON-STERILE

1 INSTANT COLD PACK 4" X 6"

1 BURN JEL 1/8 OZ, 6 PER

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

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 F. A. INST CHART SM (INDIVIDUAL LBL)

1 CPR KIT-MASK, GLOVES, WIPES

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 BODY FLUID CLEAN UP KIT BAG

1 KIT STL BULK MEDIUM

Burn Jel Principal Display Panel

Paws Principal Display Panel

4007 Kit Label 34TP165

4013 Kit Label 34T150

INGREDIENTS AND APPEARANCE

4007 FIRST AID KIT 
4007 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4007-01	1 in 1 KIT	09/12/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	21 mL
Part 2	2 PACKET	0.0038 L

Part 1 of 2

BURN JEL 
gel for burns gel

Product Information
Item Code (Source)	NDC: 0498-0202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0202-00	3.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/08/2017

Part 2 of 2

PAWS 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 0498-3111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	665 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.0019 L in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/12/2018

4013 FIRST AID KIT 
4013 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4013-01	1 in 1 KIT	09/12/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	21 mL
Part 2	2 PACKET	0.0038 L

Part 1 of 2

BURN JEL 
gel for burns gel

Product Information
Item Code (Source)	NDC: 0498-0202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0202-00	3.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/08/2017

Part 2 of 2

PAWS 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 0498-3111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	665 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.0019 L in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/12/2018

Labeler - Honeywell Safety Products USA, Inc. (079287321)

Registrant - Honeywell Safety Products US, Inc. (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-4007, 0498-4013)