Label: PAIN THERAPY- menthol, methyl salicylate cream
- NDC Code(s): 76348-640-04
- Packager: Renu Laboratories, Inc.
- 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 May 14, 2021
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- Warnings
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Inactive Ingredients
Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.
- ARCTIC HEAT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN THERAPY
menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-640 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.24 g in 112 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 11.2 g in 112 g Inactive Ingredients Ingredient Name Strength PEG-100 STEARATE (UNII: YD01N1999R) TABASCO PEPPER (UNII: J1M3NA843L) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) LAURETH-7 (UNII: Z95S6G8201) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) EMU OIL (UNII: 344821WD61) EUCALYPTUS OIL (UNII: 2R04ONI662) NIACINAMIDE (UNII: 25X51I8RD4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) WATER (UNII: 059QF0KO0R) PEPPERMINT OIL (UNII: AV092KU4JH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-640-04 112 g in 1 TUBE; Type 0: Not a Combination Product 05/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/14/2021 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-640)