Label: MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 0904-5694-01 - Packager: Major Pharmaceuticals
- 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 December 4, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- adults and children 12 years:
- remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle
- carefully remove backing from patch
- apply one patch to affected area
- wear one patch up to 8 hours
- repeat as necessary, but no more than 4 times daily
children 12 years or younger:
- consult a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients 1,3-butlene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5694 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) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) PARAFFIN (UNII: I9O0E3H2ZE) MAGALDRATE (UNII: 6V88E24N5T) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM METAPHOSPHATE (UNII: 532IUT7IRV) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 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:0904-5694-01 1 in 1 PACKAGE 06/30/2013 1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/30/2013 Labeler - Major Pharmaceuticals (191427277)