TERRASIL ANTI-FUNGAL TREATMENT (CLOTRIMAZOLE 1.0%) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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TERRASIL ANTI-FUNGAL TREATMENT (CLOTRIMAZOLE 1.0%) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-107-44
Set ID 63ea5248-7722-4c66-b11c-fdebfb9a8ca0
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active Ingredient

    Clotrimazole 1.0%

  • Purpose

    Antifungal

  • Uses

    • Cures most fungal skin infections, including ringworm and tinea. 
    • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
  • Warnings

    For external use only. Do not use on children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help.

  • Directions

    Wash and dry affected skin. Apply a thin layer of Terrasil over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature.

  • Inactive Ingredients

    (Organic) Beeswax, Bentonite, Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Tea Tree Oil, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

    Jar LabelPlace holder text

  • INGREDIENTS AND APPEARANCE
    TERRASIL ANTI-FUNGAL TREATMENT  
    clotrimazole 1.0% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-107-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/26/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture, label
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