Label: PERSONAL CARE EXTRA STRENGTH COLD HOT- menthol patch
-
Contains inactivated NDC Code(s)
NDC Code(s): 29500-9083-3 - Packager: PERSONAL CARE PRODUCTS, LLC
- 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 28, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- 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
-
INDICATIONS & USAGE
Directions
adults and children 12 years of age and older
- partially peel back protective film and apply exposed patch to site of pain
- carefully remove remaining film while pressing patch to skin for secure adhesion
- repeat as necessary, but not more than 3 to 4 times daily
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monsterarate, polysorbate 80,
polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate (Vitamin E).
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PERSONAL CARE EXTRA STRENGTH COLD HOT
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CASTOR OIL (UNII: D5340Y2I9G) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) MAGNESIUM ALUMINOMETASILICATE TYPE I-A (UNII: 7LVU907546) PEG-120 Stearate (UNII: 0V73PIX5YC) povidone K90 (UNII: RDH86HJV5Z) sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J) 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:29500-9083-3 1 in 1 CARTON 1 2 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/20/2011 Labeler - PERSONAL CARE PRODUCTS, LLC (966155082) Registrant - UNITED EXCHANGE CORP (840130579) Establishment Name Address ID/FEI Business Operations PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD 528194366 manufacture(29500-9083) Establishment Name Address ID/FEI Business Operations Yongkang Bangli Medical Products Co Ltd 723738741 manufacture(29500-9083)