Label: MUSCLE RUB- pain relieve cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72004-002-35 - Packager: AFN BROKER LLC
- 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 January 10, 2019
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INGREDIENTS AND APPEARANCE
MUSCLE RUB
pain relieve creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72004-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.3 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.04 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCOL STEARATE SE (UNII: 6YLY96TQL6) 0.025 g in 100 g EDETATE DISODIUM (UNII: 7FLD91C86K) 0.02 g in 100 g ACETYLATED LANOLIN (UNII: 2X654GD19H) 0.05 g in 100 g POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) 0.008 g in 100 g POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g in 100 g WATER (UNII: 059QF0KO0R) 0.264 g in 100 g STEARIC ACID (UNII: 4ELV7Z65AP) 0.08 g in 100 g TROLAMINE (UNII: 9O3K93S3TK) 0.75 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72004-002-35 35 g in 1 JAR; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2018 Labeler - AFN BROKER LLC (030117252)
