Label: WELLPATCH WARMING PAIN RELIEF- capsaicin patch
- NDC Code(s): 10742-8127-1, 10742-8127-2
- 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
- use only as directed
- do not use at least 1 hours before, or immediately after, a bath or shower
- 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
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING
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Inactive ingredients
carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid
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INGREDIENTS AND APPEARANCE
WELLPATCH WARMING PAIN RELIEF
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 25 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CASTOR OIL (UNII: D5340Y2I9G) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) PROPYLENE GLYCOL CAPRYLATE (UNII: RT9P9S09QI) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8127-1 1 in 1 POUCH; Type 0: Not a Combination Product 12/05/2016 2 NDC:10742-8127-2 4 in 1 POUCH; Type 0: Not a Combination Product 12/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/05/2016 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 label(10742-8127) Establishment Name Address ID/FEI Business Operations Mentholatum China Pharmaceuticals Co. Ltd. 420786030 manufacture(10742-8127)
