Label: EXTRA LARGE COOL AND HEAT PATCH- menthol patch
- NDC Code(s): 0363-9905-03
- Packager: Walgreen 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 January 11, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PURPOSE
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA LARGE COOL AND HEAT PATCH
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9905 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9905-03 3 in 1 BOX 01/01/2020 1 9 g 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 01/01/2020 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(0363-9905)