Label: UNBURN- lidocaine hydrochloride gel
- NDC Code(s): 59898-500-10, 59898-500-14
- Packager: Water-Jel Technologies
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 1, 2017
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INGREDIENTS AND APPEARANCE
UNBURN
lidocaine hydrochloride gelProduct 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)