Label: TERRASIL JOCK-ITCH TREATMENT MAX- clotrimazole ointment

  • NDC Code(s): 24909-100-14, 24909-100-15, 24909-100-44, 24909-100-50
  • 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 8, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    Treats most jock itch (tinea cruris). For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort associated with jock itch.

  • Warnings

    For external use only. Do not use on children under 2 years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 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 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 (organic), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 14 g tube

    Jock Itch Treatment Max

  • INGREDIENTS AND APPEARANCE
    TERRASIL JOCK-ITCH TREATMENT  MAX
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-100
    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
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-100-1414 g in 1 JAR; Type 1: Convenience Kit of Co-Package05/12/201412/31/2018
    2NDC:24909-100-5050 g in 1 TUBE; Type 0: Not a Combination Product05/12/2014
    3NDC:24909-100-4444 g in 1 JAR; Type 0: Not a Combination Product05/12/201405/23/2019
    4NDC:24909-100-1514 g in 1 TUBE; Type 1: Convenience Kit of Co-Package05/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/12/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare and Topical Solution, LLC018950611manufacture(24909-100)
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