Label: MEDICATED PAIN RELIEF- menthol patch
- NDC Code(s): 67510-0301-5
- Packager: Kareway Product, 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 February 17, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
- use only as directed
- do not bandage tightly or use a heating pad
- avoid contact with eyes and mucous membrane
- do not apply to wounds or damaged skin
- do not use if you are allergic to any ingredients of this product
- Directions
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Inactive ingredients
aluminium glycinate, 1,3-butylene glycol, carboxymethyl cellulose sodium, concentrated glycerin, diethylene glycomonoethyl ether, disodium edetate, methyl parahydroxybenozate, polyacrylic acid solution, polysorbate 90, propyl parahydroxybenzoate, purified water, sodium polyacrylate, tartaric acid, titanium oxide
- package label
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INGREDIENTS AND APPEARANCE
MEDICATED PAIN RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 428.5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) 1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0301-5 1 in 1 CARTON 12/01/2011 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 09/12/2011 Labeler - Kareway Product, Inc. (121840057)