Label: MENTHOL 5% HYDROGEL- menthol, unspecified form patch
- NDC Code(s): 71391-127-05
- Packager: Unexo Life Sciences, Private Limited
- 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 January 18, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
-
Warnings
For external use only
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 a heating pad
- Avoid contact with eyes or mucous membranes
- Don't apply to wounds or damaged skin
- Do not use at the same time as other topical analgesics
-
Directions
- Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton
-
INGREDIENTS AND APPEARANCE
MENTHOL 5% HYDROGEL
menthol, unspecified form patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71391-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 600 mg Inactive Ingredients Ingredient Name Strength Butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 MW) (UNII: JZ1374NL9E) Alcohol (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Edetate disodium (UNII: 7FLD91C86K) Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6) Glycerin (UNII: PDC6A3C0OX) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) Polysorbate 80 (UNII: 6OZP39ZG8H) Polyvinyl alcohol, unspecified (UNII: 532B59J990) Propylparaben (UNII: Z8IX2SC1OH) Povidone, unspecified (UNII: FZ989GH94E) Sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J) Sorbitan monooleate (UNII: 06XEA2VD56) Sorbitol (UNII: 506T60A25R) Tartaric acid (UNII: W4888I119H) Titanium dioxide (UNII: 15FIX9V2JP) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71391-127-05 5 in 1 POUCH; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/01/2020 Labeler - Unexo Life Sciences, Private Limited (872260479) Establishment Name Address ID/FEI Business Operations Unexo Life Sciences, Private Limited 872260479 MANUFACTURE(71391-127)