Label: FLEXIN- menthol and capsaicin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69695-1974-1 - Packager: Whyteman Labs LLC
- 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 November 11, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS :
- ACTIVE INGREDIENT
- PURPOSE
- ACTIVE INGREDIENT
- PURPOSE
- USES :
- WARNINGS :
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DIRECTIONS :
- Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.
- Children under 12 years, consult a physician before use.
- How to apply:
- Clean and dry affected area.
- Cut open pouch and remove patch. Remove protective film and apply directly to area of pain.
- Apply to affected area not more than 3 times daily.
- Wash hands with soap after applying patch.
- Reseal pouch containing unused patches.
- INACTIVE INGREDIENTS :
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEXIN
menthol and capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69695-1974 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.000375 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.05 Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) EDETIC ACID (UNII: 9G34HU7RV0) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) ALOE VERA LEAF (UNII: ZY81Z83H0X) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69695-1974-1 15 in 1 BOX 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 07/13/2015 Labeler - Whyteman Labs LLC (079758831)