Label: THERACARE 5% MENTHOL PAIN RELIEF PATCH- menthol patch
- NDC Code(s): 71101-053-05
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 29, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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When using this product
When using this product
■ Use only as directed
■ Rare cases of serious burns have been reported with products of this type
■Don't bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes
■ Don't apply to wounds or damaged skin
■ Do not use at the same time as other topical analgesics.
- Stop use and ask a doctor
- If pregnant or breastfeeding
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.
Children under 12 years of age: consult a physician.
- Other Information
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INACTIVE INGREDIENT
Inactive ingredients
alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERACARE 5% MENTHOL PAIN RELIEF PATCH
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) METHYLPARABEN (UNII: A2I8C7HI9T) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) TARTARIC ACID (UNII: W4888I119H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-053-05 5 in 1 BOX 08/01/2024 1 1 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 Drug M017 08/01/2024 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Unexo Life Sciences Private Ltd. 872260479 manufacture(71101-053)