Label: EXTRA STRENGTH COLD-HOT MEDICATED PATCHES- menthol patch
- NDC Code(s): 70000-0367-1
- Packager: Cardinal Health, 110 dba LEADER
- 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 January 11, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening. Discard patch after single use. Children under 12 years of age: consult a physician.
- PURPOSE
- When using this product
- Stop use and ask a doctor
- If pregnant or breastfeeding
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH COLD-HOT MEDICATED PATCHES
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0367 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 DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0367-1 5 in 1 BOX 01/01/2019 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 not final part348 01/01/2019 Labeler - Cardinal Health, 110 dba LEADER (063997360) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd., 529128763 manufacture(70000-0367)