Label: MUSCLE RUB ULTRA- camphor,menthol, methyl salicylate cream
- NDC Code(s): 67510-0659-1, 67510-0659-2
- Packager: Kareway Product, Inc.
- 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 February 17, 2023
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- Active Ingredients
- Uses
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WARNINGS
For external use only.
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
- Directions
- Other information
- Inactive Ingredients
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- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUSCLE RUB ULTRA
camphor,menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0659 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)- 30 g in 100 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LANOLIN (UNII: 7EV65EAW6H) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0659-1 1 in 1 BOX 08/11/2011 1 35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:67510-0659-2 1 in 1 BOX 08/11/2011 2 28 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 08/11/2011 Labeler - Kareway Product, Inc. (121840057)