Label: TERRASILMED ANTIFUNGAL- clotrimazole ointment

  • NDC Code(s): 24909-026-50
  • Packager: Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • Active ingredient

    Clotrimazole 1.0%

  • Pupose

    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.

  • 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 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 twice daily or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

  • Inactive ingredients

    beeswax, MCT (coconut oil), silver stearate, sorbic acid

  • Questions?

    401-432-7750 or www.aidance.com

  • Product label

    Tube

  • INGREDIENTS AND APPEARANCE
    TERRASILMED ANTIFUNGAL 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-026
    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)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-026-5050 g in 1 TUBE; Type 0: Not a Combination Product11/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/08/2023
    Labeler - Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-026)
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