Label: JOINT AND MUSCLE PAIN- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55379-404-85 - Packager: BioZone Laboratories, 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 July 28, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Directions
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Warnings
- For external use only. Do not use with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
- Avoid contact with eyes.
- Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
- Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
- Directions
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Inactive Ingredients
Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JOINT AND MUSCLE PAIN
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55379-404 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 50 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55379-404-85 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/15/2009 Labeler - BioZone Laboratories, Inc. (555564293)
