Label: UNBURN- lidocaine hydrochloride spray
- NDC Code(s): 59898-510-45
- Packager: Water-Jel Technologies
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 30, 2017
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INGREDIENTS AND APPEARANCE
UNBURN
lidocaine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-510 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 ALOE (UNII: V5VD430YW9) CAPRYLIC ALCOHOL (UNII: NV1779205D) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SPEARMINT OIL (UNII: C3M81465G5) TEA TREE OIL (UNII: VIF565UC2G) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59898-510-45 150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2014 Labeler - Water-Jel Technologies (155522589) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(59898-510)