Burn Jel (Lidocaine Hydrochloride) Gel [Water-Jel Technologies] -

BURN JEL (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES]
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NDC	59898-200-10, 59898-200-11, 59898-200-12, 59898-200-13, 59898-200-15, 59898-200-16, 59898-200-17, 59898-200-35, 59898-200-49
Set ID	ff621b46-2342-41db-994d-851a09796d08
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 2.0 %
Purpose

External analgesic
Uses

for the temporary relief of pain associated with minor burns
Warnings
For external use only
Do not use
- on large areas of the body
- on broken, blistered or oozing skin
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 the 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
- spread a thick even layer over affected skin
- children under 2 years of age: consult a doctor
Other information
- store at room temperature
- do not use if opened or torn
- you may report a serious adverse reaction to this product to 800-275-3433
Inactive ingredients

triethanolamine, melaleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea,

methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA
Questions or comments?

1-800-275-3433 info@waterjel.com www.waterjel.com
Principal Display Panel

INGREDIENTS AND APPEARANCE

BURN JEL
lidocaine hydrochloride gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 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 HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59898-200-13	24 in 1 CARTON	04/17/2010
1	NDC:59898-200-12	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59898-200-16	6 in 1 BOX	04/17/2010
2		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC:59898-200-11	24 in 1 CARTON	04/17/2010
3	NDC:59898-200-10	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59898-200-17	1728 in 1 CARTON	04/17/2010
4		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC:59898-200-35	3.5 mL in 1 PACKET; Type 0: Not a Combination Product	04/17/2010
6	NDC:59898-200-15	25 in 1 BOX	04/17/2010
6		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
7	NDC:59898-200-49	10 in 1 KIT	04/17/2010
7		3.5 mL 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	04/17/2010

Labeler - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-200)

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Medic