Label: PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL EXTRA STRENGTH- camphor, menthol gel
- NDC Code(s): 70039-283-07
- 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 10, 2016
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- Official Label (Printer Friendly)
- 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.
- Directions:
- Other Information:
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Inactive Ingredients:
Alcohol Denat., Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint Oil), Propylene Glycol, Glycerin, MSM (Methylsulfonylmethane), Boswellia Serrata Extract, Ilex Paraguensis (Yerba Mate Ilex) Extract, Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine.
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL EXTRA STRENGTH
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70039-283 Route of Administration CUTANEOUS, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 40 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) WATER (UNII: 059QF0KO0R) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT OIL (UNII: AV092KU4JH) GLYCERIN (UNII: PDC6A3C0OX) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70039-283-07 1 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 06/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2015 Labeler - Active and Innovative Inc. (206978079) Establishment Name Address ID/FEI Business Operations PureTek Corp. 785961046 manufacture(70039-283)
