Label: MUSCLE RUB- menthol, unspecified form and methyl salicylate cream
- NDC Code(s): 50382-015-15
- Packager: Galentic Pharma (India) Private Limited
- Category: HUMAN OTC DRUG LABEL
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 28, 2022
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- Official Label (Printer Friendly)
- • ACTIVE INGREDIENT
- • PURPOSE
- • USES
-
• WARNINGS
For external use only
Do not use
- On wounds or damaged skin
- With a heating pad
- On a child under 12 years of age with arthritis-like conditions
- • DIRECTIONS
- • OTHER INFORMATION
- • INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
MUSCLE RUB
menthol, unspecified form and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) LANOLIN (UNII: 7EV65EAW6H) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-015-15 1 in 1 CARTON 06/01/2012 1 85 g in 1 TUBE; 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 06/01/2012 Labeler - Galentic Pharma (India) Private Limited (915110464) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 650970176 analysis(50382-015) , manufacture(50382-015) , pack(50382-015) , sterilize(50382-015)