Label: MENTHOLATUM LIDOCAINE ICE- lidocaine hcl, menthol gel
- NDC Code(s): 10742-1389-1
- Packager: The Mentholatum Company
- 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 February 7, 2023
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- Active ingredients
- Purpose
- Uses
- Warnings
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
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Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimecthicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, ethoxydiglycol, glycerin, glyceryl monostearate, methoxypropanediol, phenoxyethanol, purified water, steareth-21
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INGREDIENTS AND APPEARANCE
MENTHOLATUM LIDOCAINE ICE
lidocaine hcl, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1389 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 PHOSPHATE (UNII: 921FTA1500) CHLORPHENESIN (UNII: I670DAL4SZ) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN METHYL ETHER (UNII: 42ESM1DR47) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) STEARETH-21 (UNII: 53J3F32P58) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1389-1 1 in 1 CARTON 08/01/2018 1 80 mL in 1 BOTTLE; 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 08/01/2018 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-1389)