Label: DYNAREX MUSCLE RUB CREAM- menthol and methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-416-01 - Packager: Dynarex Corporation
- 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 June 15, 2017
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INGREDIENTS AND APPEARANCE
DYNAREX MUSCLE RUB CREAM
menthol and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) ALLANTOIN (UNII: 344S277G0Z) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-416-01 85 g in 1 TUBE; Type 0: Not a Combination Product 05/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/16/2016 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)