Label: TERRASIL ANTI-FUNGAL TREATMENT- clotrimazole ointment

  • NDC Code(s): 24909-218-14
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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 May 27, 2022

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  • Active Ingredient and Purpose

    Clotrimazole 1% - Antifungal

  • Uses

    Treats 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, get medical help or contact a Poison Control Center right away.​

  • Directions

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

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay)*, cottonseed oil* jojoba seed oil, magnesium oxide, peppermint oil, silver stearate, sunflower oil*, tea tree oil, zinc oxide
    ◊6x the fungal fighting power of other brands - data on file.
    *may contain this ingredient.

  • Questions?

    401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL ANTI-FUNGAL TREATMENT 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-218-1414 g in 1 TUBE; Type 0: Not a Combination Product09/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-218)
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