Label: MENTHOZEN CREAM- methyl salicylate, menthol, capsaicin cream
- NDC Code(s): 71205-771-72
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 71574-605
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS:
- ACTIVE INGREDIENTS:
- USES:
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WARNINGS:
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- For external use only.
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- Avoid contact with the eyes.
- •
- If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.
- DIRECTIONS
- OTHER INFORMATION:
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INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguariensis (Yerba Mate) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
MENTHOZEN CREAM
methyl salicylate, menthol, capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-771(NDC:71574-605) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 200 mg in 1 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 50 mg in 1 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.375 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA WHOLE (UNII: O80TY208ZW) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CETYL ALCOHOL (UNII: 936JST6JCN) DMDM HYDANTOIN (UNII: BYR0546TOW) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-771-72 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 09/01/2022 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-771)