Label: ULTRA STRENGHT MUSCLE RUB- methyl salicylate, menthol cream
- NDC Code(s): 72667-010-01
- Packager: Inspec Solutions 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.
Updated May 7, 2019
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- ACTIVE INGREDIENT
Menthol - 8.00%
Methyl Salicylate - 30.00%Close
Menthol - 8.00% .................................................. External Analgesic
Methyl Salicylate - 30.00% ................................. External AnalgesicClose
- INDICATIONS & USAGE
Uses Temporary relief for minor aches and pains of muscles and joints.Close
For external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.Close
- STOP USE
Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.Close
- DOSAGE & ADMINISTRATION
Use only as directed. Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.Close
- INACTIVE INGREDIENT
- INGREDIENTS AND APPEARANCE
ULTRA STRENGHT MUSCLE RUB
methyl salicylate, menthol cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-010 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 8 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM STEARATE (UNII: 17V812XK50) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL PHOSPHATE (UNII: VT07D6X67O) WATER (UNII: 059QF0KO0R) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-010-01 113 mL in 1 TUBE; Type 0: Not a Combination Product 05/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/07/2019 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-010)