Label: MUSCLE AND JOINT- menthol, unspecified form gel
- NDC Code(s): 50382-016-15
- Packager: Galentic Pharma (India) Private Limited
- 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 28, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- • ACTIVE INGREDIENT
- • PURPOSE
- • USES
-
• WARNINGS
For External Use Only.
Do not use
- On wounds or damaged skin
- With a heating pad
- On children under 12 years of age with arthritis-like conditions
- • DIRECTIONS
- • OTHER INFORMATION
- • INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
MUSCLE AND JOINT
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-016 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 25 mg in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) POLYSORBATE 60 (UNII: CAL22UVI4M) METHYLPARABEN (UNII: A2I8C7HI9T) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-016-15 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(50382-016) , manufacture(50382-016) , pack(50382-016) , sterilize(50382-016)