Label: TERRASIL ANTI-FUNGAL TREATMENT- clotrimazole 1.0% ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 26, 2012

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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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