Label: PROFESSIONAL THERAPY MUSCLE CARE PAIN RELIEVING GEL BY DR. CHRIS OSWALD MAXIMUM STRENGTH- menthol, camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49795-416-85 - Packager: Nutri-Dyn Products Ltd. dba Professional Health Products
- 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 January 18, 2010
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- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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WARNINGS AND PRECAUTIONS
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.
- Discontinue use if excessive irritation of the skin develops.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DESCRIPTION
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- REFERENCES
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INGREDIENTS AND APPEARANCE
PROFESSIONAL THERAPY MUSCLE CARE PAIN RELIEVING GEL BY DR. CHRIS OSWALD MAXIMUM STRENGTH
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49795-416 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 Camphor (UNII: 5TJD82A1ET) (Camphor - UNII:5TJD82A1ET) Camphor 4 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Eucalyptus oil (UNII: 2R04ONI662) Peppermint oil (UNII: AV092KU4JH) Propylene glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) Dimethyl sulfone (UNII: 9H4PO4Z4FT) Glucosamine sulfate (UNII: 1FW7WLR731) Magnesium chloride (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49795-416-85 85 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/15/2010 Labeler - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511) Registrant - Ergo-Health a division of Active & Innovative Inc. (206978079)