Label: TERRASIL ATHLETES FOOT ANTIFUNGAL TREATMENT MAX- clotrimazole ointment

  • NDC Code(s): 24909-207-25, 24909-207-28
  • Packager: Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

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

  • Warnings

    For external use only. Do not use onchildren 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 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 layer of ointment over affected area daily for 4 weeks or as directed by a doctor. Pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. This product is not effective on the scalp or nails.

  • Inactive Ingredients

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

  • Other information

    Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight

  • Questions?

    401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL ATHLETES FOOT ANTIFUNGAL TREATMENT MAX 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-207
    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)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-207-2525 g in 1 TUBE; Type 0: Not a Combination Product01/05/2022
    2NDC:24909-207-2828 g in 1 TUBE; Type 0: Not a Combination Product11/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/05/2022
    Labeler - Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions018950611label(24909-207) , manufacture(24909-207)
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