Label: PROFESSIONAL THERAPY MUSCLECARE EXTRA STRENGTH- menthol, camphor gel
- NDC Code(s): 70039-200-02
- Packager: Active and Innovative 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 August 3, 2021
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENTS (% BY WEIGHT) PURPOSE
- USES:
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WARNINGS:
For external use only.
Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Do not apply to wounds or damaged skin. Do not bandage tightly.
- KEEP OUT OF REACH OF CHILDREN:
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients: Peppermint leaf oil (Mentha piperita), Eucalyptus globus leaf oil, Dimethyl sulfone (MSM), Boswellia Carterii Extract, Ilex Paraguariensis (Mate) leaf extract, Glucosamine sulfate, Chondroitin sulfte, Magnesium chloride, Tocopherol (natural Vitamin E), Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Water, Ethanol, Glycerin, UREA, Hydroxypropyl methylcellulose.
- Professional Therapy MuscleCare Extra Strength Pain Relieving Gel by Dr. Chris Oswald
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INGREDIENTS AND APPEARANCE
PROFESSIONAL THERAPY MUSCLECARE EXTRA STRENGTH
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70039-200 Route of Administration CUTANEOUS, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 40 mg in 1 g Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) PEPPERMINT OIL (UNII: AV092KU4JH) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) TOCOPHEROL (UNII: R0ZB2556P8) THYMOL (UNII: 3J50XA376E) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) UREA (UNII: 8W8T17847W) HYPROMELLOSES (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70039-200-02 85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2017 Labeler - Active and Innovative Inc. (206978079) Establishment Name Address ID/FEI Business Operations Delta Pharma Inc. 200161730 manufacture(70039-200) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 manufacture(70039-200)