SANAFITIL TALCO (UNDECYLENIC ACID AND ZINC UNDECYLENATE) POWDER [ZURICH MEDICAL LABS, LLC]

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SANAFITIL TALCO (UNDECYLENIC ACID AND ZINC UNDECYLENATE) POWDER [ZURICH MEDICAL LABS, LLC]
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NDC 61357-152-01
Set ID 105c961c-81ee-4b44-b39e-1501132114f0
Category HUMAN OTC DRUG LABEL
Packager ZURICH MEDICAL LABS, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Undecylenic Acid 2%Antifungal
    Zinc Undecylenate 20%Antifungal
  • Uses

    • Cures most athlete's foot, jock itch & ringworm
    • Relieves itching, burning, cracking, and discomfort which accompany these conditions
  • Warning

    • For external use only.
    • Not for diaper rash

    • When using this product avoid contact with eyes and mucous membrane.

    • Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    Stop use and ask a doctor if

    • Irritation occurs
    • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

    KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion seek professional assistance or contact a poison control center right away.

  • Directions

    • Clean affected area and dry thoroughly.
    • Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.
    • For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
    • For athlete's foot and ringworm, use daily for 4 weeks
    • For jock itch use daily for 2 weeks.
    • Supervise Children in use of this product.
    • Product not effective in the scalp or nails.
  • Other Information

    Store at 59° - 86° F

  • Other ingredients

    talc

  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

    SANAFITIL®

    ANTIFUNGAL
    POWDER

    • Treats most Athlete's foot, Jock itch & Ringworm

    NET WEIGHT / PESO
    NETO : 2 OZ (57 g)

    Principal Display Panel - 57 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SANAFITIL TALCO 
    undecylenic acid and zinc undecylenate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID20 mg  in 1 g
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61357-152-011 in 1 CARTON
    157 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C08/24/1966
    Labeler - ZURICH MEDICAL LABS, LLC (071904097)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-152)
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