Label: MEDICATED PAIN RELIEF HOT- menthol, capsicum extract patch
- NDC Code(s): 67510-0126-2, 67510-0126-4
- Packager: Kareway Product, 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 February 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Uses
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Warnings
For external use only
When using this product
- use only as directed
- do not bandage tightly
- do not use a heating pad
- avoid contact with eyes and mucous membrane
- do not apply to wounds or damaged skin
- do not use if you are allergic to any ingredients of this product
- Directions
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
MEDICATED PAIN RELIEF HOT
menthol, capsicum extract patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 24 mg CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.12 mg Inactive Ingredients Ingredient Name Strength POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POVIDONE (UNII: FZ989GH94E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0126-2 1 in 1 CARTON 12/01/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67510-0126-4 1 in 1 CARTON 12/01/2017 2 4 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 12/01/2017 Labeler - Kareway Product, Inc. (121840057)