Label: EXTRA STRENGTH PAIN RELIEF THERAPY- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-703-05 - Packager: United Exchange Corp
- 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 September 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INDICATIONS & USAGE
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients 1,3-butylene glycol, aloe vera (powder), metacrylic acid butylacrylate copolymer, dibutylhydroxytoluene, disodium edetate, D-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF THERAPY
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) LIGHT MINERAL OIL (UNII: N6K5787QVP) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-703-05 5 in 1 POUCH; Type 0: Not a Combination Product 06/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/30/2013 Labeler - United Exchange Corp (840130579)