Label: WELLPATCH COOLING PAIN RELIEF- menthol patch
- NDC Code(s): 10742-8125-1
- Packager: The Mentholatum Company
- 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 7, 2023
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- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- use only as directed
- avoid contact with eyes and mucous membranes
- do not apply to wounds or to damaged or very sensitive skin
- do not bandage tightly or use with a heating pad
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Directions
- adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
- children under 12 years: ask a doctor
- FOR BEST RESULTS apply to clean, dry skin
- tear open pouch and remove patch; if desired, cut patch to size
- grasp both ends of the patch firmly with thumbs near center
- stretch patch until the backing separates
- remove protective film while applying patch directly to site of pain
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Inactive ingredients
carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid
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INGREDIENTS AND APPEARANCE
WELLPATCH COOLING PAIN RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 50 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8125-1 1 in 1 POUCH; Type 0: Not a Combination Product 02/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/06/2017 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8125) Establishment Name Address ID/FEI Business Operations Mentholatum China Pharmaceuticals Co. Ltd. 420786030 manufacture(10742-8125)