Label: COLD AND HOT PAIN RELIEF- menthol patch
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NDC Code(s):
67510-0300-2,
67510-0300-3,
67510-0300-4,
67510-0300-5, view more67510-0300-6
- 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 Ingredient
- Purpose
- 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
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Directions
Adults and children over 12 years:
- Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
- Carefully remove backing from patch
- Apply one patch to affected area
- Repeat as necessary, but no more than 4 times daily
Children under 12 years of age: Ask a doctor
- Other information
- Inactive ingredients
- package label
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INGREDIENTS AND APPEARANCE
COLD AND HOT PAIN RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 400 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) KAOLIN (UNII: 24H4NWX5CO) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0300-2 1 in 1 CARTON 02/21/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67510-0300-4 1 in 1 CARTON 02/21/2017 2 4 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:67510-0300-3 1 in 1 CARTON 02/21/2017 3 3 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:67510-0300-5 1 in 1 CARTON 02/21/2017 4 5 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:67510-0300-6 1 in 1 CARTON 02/21/2017 5 6 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 02/21/2017 Labeler - Kareway Product, Inc. (121840057)