Label: MUSCLE RUB- menthol gel
- NDC Code(s): 52000-020-37, 52000-020-38
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 21, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.
- Avoid contact with eyes or mucous membranes.
- Discontinue use if excessive irritation of the skin develops.
- Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
- If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
- For arthritis like conditions in children under 12, do not use. Consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUSCLE RUB
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.025 g in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 940 (UNII: 4Q93RCW27E) DMDM HYDANTOIN (UNII: BYR0546TOW) ISOCETETH-20 (UNII: O020065R7Z) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-020-37 1 in 1 BOX 12/13/2020 1 NDC:52000-020-38 35 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 04/15/2015 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-020)