Label: NUTRA NAIL FUNGI FREE ANTIFUNGAL TREATMENT- undecylenic acid liquid

  • 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 August 13, 2014

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  • Nutra Nail FUNGI FREE Antifungal Treatment


  • ACTIVE INGREDIENT


    Active ingredient / Purpose

    Undecylenic acid 25% .................................................................. Antifungal

  • Uses

    Cures most

    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)

    Relieves

    • itching
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort associated with these conditions

  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor

    When using this product
    • avoid contact with eyes
    Stop use and ask a doctor if
    • irritation occurs
    • there is no improvement in 4 weeks

    Keep out of reach of children

    • in case of ingestion, get medical help or contact a Poison Control Center right away
  • Directions

    • clean affected area with soap and warm water and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
    • the precision flow applicator allows for easy application under nails and surrounding cuticle area
    • wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • for athlete's foot pay special attention to spaces between the toes
    • for athlete's foot and ringworm, use daily for 4 weeks
    • if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
    • supervise children in use of this product
  • Other Information

    • store at room temperature 15 degrees - 30 degrees C (59 degrees -  86 degrees F)
    • protect from freezing. If freezing occurs warm to room temperature
  • Inactive Ingredients

    • aloe barbadensis leaf extract, benzyl alcohol, isoamyl laurate, tocopheryl acetate
  • Questions or comments?

    • Call 1-800-595-6230
  • Nutra Nail FUNGI FREE Antifungal Treatment 13ml (61543-2285-5)

    NutraNailOuterBox

    NutraNailInnerLabel

  • INGREDIENTS AND APPEARANCE
    NUTRA NAIL FUNGI FREE ANTIFUNGAL TREATMENT 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-2285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOAMYL ACETATE (UNII: Z135787824)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-2285-515 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/13/2014
    Labeler - CCA Industries, Inc (106771041)
    Registrant - CCA Industries, Inc (106771041)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.010297942manufacture(61543-2285)
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