Label: TERRASIL TINEA TREATMENT MAX- clotrimazole ointment

  • NDC Code(s): 24909-104-14, 24909-104-15, 24909-104-20, 24909-104-44, view more
    24909-104-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For external use only. Do not useon 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.

  • Directions

    Wash and dry affected skin. Apply a thin layer of ointment 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. May stain fabrics.

  • Inactive Ingredients

    beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

  • Product label

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  • INGREDIENTS AND APPEARANCE
    TERRASIL TINEA TREATMENT   MAX
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-104
    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)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PALM OIL (UNII: 5QUO05548Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-104-1414 g in 1 JAR; Type 0: Not a Combination Product05/12/201405/21/2018
    2NDC:24909-104-4444 g in 1 JAR; Type 0: Not a Combination Product05/12/201405/21/2018
    3NDC:24909-104-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    4NDC:24909-104-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    5NDC:24909-104-20200 g in 1 JAR; Type 0: Not a Combination Product05/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/12/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-104)
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