4019 First Aid Kit Kit [Honeywell Safety Products Usa, Inc.] -

4019 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]
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NDC	0498-0203-00, 0498-4019-01
Set ID	78278946-79cb-0d00-e053-2991aa0a2c84
Category	HUMAN OTC DRUG LABEL
Packager	Honeywell Safety Products USA, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number

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Active ingredient

Lidocaie HCl 2%
Purpose

External analgesic
Uses

temporarily relieves pain due to minor burns
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.
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
Other information
- store at room temperature
- do not use if opened or torn
Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water
Questions

1-800-430-5490
4019 Kit 6824BURNKEY Contents

1- Por. Cloth Tape 1" X 10 yd

1- Gauze Bandage 2" X 2 yds stretch gauze

1- Co-flex Bandage 1 & 1/2" X 5yd Tan

1- Water Jel Burn Jel 3.5g packet 6 ct

1- Calcium Gluconate 25g tube

1- Scissor Lister Bandage S/S 5 & 1/2"

1- Pair Large Nitrile Gloves

1- Water-Jel Burn Dressing 8" X 18"

1- Water Jel Burn Dressing 4" X 16"

3- Water-Jel Burn Dressing 2" X 6"

3- Water-Jel Burn Dressing 2" X 6"
Burn Jel Principal Display Panel
4019 Kit Label 6824BURNKEY

INGREDIENTS AND APPEARANCE

4019 FIRST AID KIT
4019 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4019

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4019-01	1 in 1 KIT	10/13/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	6 PACKET	21 g

Part 1 of 1

BURN JEL
gel for burns gel

Product Information
Item Code (Source)	NDC:0498-0203
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0203-00	3.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/13/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Honeywell Safety Products USA, Inc.		079287321	pack(0498-4019)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(0498-0203)

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Medic

4019 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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