Label: CORALITE EXTRA STRENGTH COOL AND HOT- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-145-05 - Packager: United Exchange Corp.
- 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 December 31, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate, Release Liner: polypropylene, non-woven material: polyester non-woven fabric
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CORALITE EXTRA STRENGTH COOL AND HOT
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-145 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CASTOR OIL (UNII: D5340Y2I9G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-145-05 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 12/30/2014 Labeler - United Exchange Corp. (840130579)