BURN JEL- lidocaine hydrochloride gel

Burn Jel by

Drug Labeling and Warnings

Burn Jel by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/17/2010

Labeler - Water-Jel Technologies (155522589)

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