UNBURN- lidocaine hydrochloride gel

Unburn by

Drug Labeling and Warnings

Unburn 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 2.5%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with:

• sunburn
• minor burns
• minor skin irritations
• insect bites
  

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

• condition 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
• children under 2 years of age: consult a doctor
  

Other information

• store at 15 o to 25 oC (59 o to 77 oF)
• do not freeze
• you may report a serious adverse reaction to this product to 1-800-275-3433
  

Inactive ingredients

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

QUESTIONS

1-800-275-3433

Monday - Friday (9a.m. - 5 p.m. EST)

www.unburn.info

Principle Display Panel

INGREDIENTS AND APPEARANCE

UNBURN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-500
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SPEARMINT OIL (UNII: C3M81465G5)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-500-10	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/17/2013
2	NDC: 59898-500-14	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/17/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/17/2013

Labeler - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-500)