UNBURN- lidocaine hydrochloride gel 
Water-Jel Technologies

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Water-Jel Unburn

Active ingredient

Lidocaine HCl 2.5%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with:

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

Other information

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

1-800-275-3433

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

www.unburn.info

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Unburn

UNBURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-500-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/17/2013
2NDC:59898-500-14240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/17/2013
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-500)

Revised: 12/2017
Document Id: 5f4b97f0-64af-6766-e053-2a91aa0abc98
Set id: 0c504ba8-8a40-43dd-8c68-62ed106b32a2
Version: 2
Effective Time: 20171201
 
Water-Jel Technologies