Label: COLD AND HOT MEDICATED PAIN RELIEF LARGE- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 63941-948-05 - Packager: Valu Merchandisers Company, Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 6, 2022
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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
- do not bandage tightly or use with heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
- do not use if you are allergic to any ingredients of this product
- Directions
- Inactive ingredients
- Questions or Comments?
- package label
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INGREDIENTS AND APPEARANCE
COLD AND HOT MEDICATED PAIN RELIEF LARGE
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-948 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 550 mg Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POVIDONE (UNII: FZ989GH94E) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLPARABEN (UNII: Z8IX2SC1OH) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-948-05 1 in 1 CARTON 07/06/2022 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 07/06/2022 Labeler - Valu Merchandisers Company, Inc. (868703513)