Label: ASSURED COLD N HOT PAIN RELIEF MENTHOL- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-6159-5 - Packager: Greenbrier International, 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 October 28, 2020
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
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- open pouch and remove patch
- carefully peel off protective packing and apply sticky side to affected area
- adults and children 12 years of age and older:
- do not wear patch for more than 8 hours
- apply to affected area no more than 3 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
aloe vera, aluminum hydroxide, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methyl paraben, peg monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric dioxide, tocopherol acetate
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASSURED COLD N HOT PAIN RELIEF MENTHOL
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-6159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CASTOR OIL (UNII: D5340Y2I9G) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-6159-5 2 in 1 PACKET 10/17/2014 1 5 mg 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 10/17/2014 Labeler - Greenbrier International, Inc (610322518)