NUTRA NAIL FUNGI FREE ANTIFUNGAL TREATMENT (UNDECYLENIC ACID) LIQUID [CCA INDUSTRIES, INC]

NUTRA NAIL FUNGI FREE ANTIFUNGAL TREATMENT (UNDECYLENIC ACID) LIQUID [CCA INDUSTRIES, INC]
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NDC 61543-2285-5
Set ID 35059457-4f70-4ba6-9c7c-dce940386306
Category HUMAN OTC DRUG LABEL
Packager CCA Industries, Inc
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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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