Burn Jel Plus (Gel For Burns) Gel [Water-Jel Technologies] -

BURN JEL PLUS (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]
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NDC	59898-202-10, 59898-202-11, 59898-202-12, 59898-202-13
Set ID	401023a5-6634-4c04-b6a6-55b78a9c79fe
Category	HUMAN OTC DRUG LABEL
Packager	Water-Jel Technologies
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Active ingredient

Lidocaine HCl 2.5%
Purpose

External analgesic
Uses

for the temporary relief of pain associated with minor burns
Warnings
For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas
When using this product
- avoid contact with eyes
Stop use and ask a doctor if
- conditions worsens
- symptoms persist for more than 7 days
- condition clears up and occurs again 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: consult a doctor
Inactive ingredients

carbomer 940, carbomer 1342, diazolidinyl urea, edetate disodium, glycerin, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine, vitamin E acetate
Questions ?

1-800-275-3433 www.waterjel.com
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INGREDIENTS AND APPEARANCE

BURN JEL PLUS
gel for burns gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
CARBOMER COPOLYMER TYPE B (UNII: 1G56KV7BUJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59898-202-10	1 in 1 CARTON	04/10/2010
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59898-202-11	24 in 1 CARTON	04/10/2010
2		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:59898-202-12	1 in 1 CARTON	04/10/2010
3		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59898-202-13	24 in 1 CARTON	04/10/2010
4		118 mL in 1 BOTTLE, PLASTIC; 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	04/10/2010

Labeler - Water-Jel Technologies (155522589)

Registrant - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-202)

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Medic