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
you may report a serious adverse reaction to this product to 800-275-3433

Inactive ingredients

acrylates/C10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

Questions or comments?

1-800-275-3433 info@waterjel.com www.waterjel.com
Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,
Carlstadt, NJ 07072, USA

Principal Display Panel

Principal Display Label BJ2RD BJ4RD

BURN JEL
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59898-200
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 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)

Burn Jel