Label: FLEXIN- menthol and capsaicin patch

  • 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 November 11, 2015

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  • DRUG FACTS :

  • ACTIVE INGREDIENT

    Menthol 5.00%

  • PURPOSE

    External Analgesic/Counterirritant

  • ACTIVE INGREDIENT

    Capsaicin 0.0375%

  • PURPOSE

    External Analgesic

  • USES :

    Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

  • WARNINGS :

    • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
    • Do not cover with bandage.
    • Do not use on wounds or damaged skin.

    • Keep out of reach of children. Consult physician for use in children under 12.

    • Do not use if you are allergic to Menthol or Capsaicin.

    • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occurs again within a few days, or if rash, itching or excessive skin irritation occurs.
  • 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 :

    Water, Glycerine, Sodium Polyacrylate, Polysorbate 80,

    Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,

    Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben.

  • STORAGE AND HANDLING

    Store below 25°C (77°F)

    Avoid direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    Flexin Label

  • INGREDIENTS AND APPEARANCE
    FLEXIN 
    menthol and capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69695-1974
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.000375 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69695-1974-115 in 1 BOX
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/13/2015
    Labeler - Whyteman Labs LLC (079758831)
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