Label: GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 75981-124-05 - Packager: Geiss, Destin and Dunn, 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 June 30, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: Aloe Vera, Aluminum Hydroxide, Disodium Edate, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Polysorbate 80, Tocopherol Acetate, Magnesium Aluminometasilicate, Castor Oil, Tartaric Acid, Polyethylene Glycol Monostearate, BHT, Sodium POlyacrylate. Release liner: Polypropylene, Non-woven material: Polyester non-woven fabric
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75981-124 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GELATIN (UNII: 2G86QN327L) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CASTOR OIL (UNII: D5340Y2I9G) TARTARIC ACID (UNII: W4888I119H) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75981-124-05 5 in 1 CARTON 1 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/30/2013 Labeler - Geiss, Destin and Dunn, Inc. (076059836)