Label: SIGNATURE CARE COLD AND HOT MEDICATED- menthol patch
- NDC Code(s): 21130-980-01
- Packager: Safeway
- This is a repackaged label.
- Source NDC Code(s): 64032-8125
- 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 March 6, 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
- avoid contact with eyes or on 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 patch to affected area as needed but not more than 4 times daily
- children under 12 years: ask a doctor
- for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.
- Inactive ingredients
- Package/Label Principal Display Panel
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE COLD AND HOT MEDICATED
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-980(NDC:64032-8125) 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 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CASTOR OIL (UNII: D5340Y2I9G) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) KAOLIN (UNII: 24H4NWX5CO) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-980-01 1 in 1 CARTON 09/01/2015 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 09/01/2015 Labeler - Safeway (009137209)