Label: PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-991-01 - Packager: CVS PHARMACY, INC.
- Category: HUMAN OTC DRUG LABEL
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 September 18, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- open pouch and remove patch
- if desired, cut patch to size
- peel off protective backing and apply sticky side to affected area
- adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily
- children under 12 years of age consult a doctor
- For best results, please ensure that the skin is clean and dry before applying
- reseal pouch
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INACTIVE INGREDIENT
Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-991 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 Inactive Ingredients Ingredient Name Strength Silodrate (UNII: 9T3UU8T0QK) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Castor Oil (UNII: D5340Y2I9G) Carboxymethylcellulose Sodium (UNII: K679OBS311) Edetate Disodium (UNII: 7FLD91C86K) Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Isopropyl Myristate (UNII: 0RE8K4LNJS) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) Peg-4 Stearate (UNII: J33E8608YN) Polysorbate 80 (UNII: 6OZP39ZG8H) Polyvinyl Alcohol (UNII: 532B59J990) Water (UNII: 059QF0KO0R) Tartaric Acid (UNII: W4888I119H) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-991-01 5 in 1 BOX 1 1 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/15/2013 Labeler - CVS PHARMACY, INC. (062312574)