Label: TERRASIL ANTIFUNGAL CREAM MAXIMUM STRENGTH- clotrimazole cream

  • NDC Code(s): 24909-208-50
  • Packager: Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
  • 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 February 18, 2022

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    Cures 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 thin layer of cream 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

    cotton seed oil, distilled water, emulsifying wax, Jojoba seed oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide

  • Questions?

    401-432-7750 or www.aidance.com

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    TERRASIL ANTIFUNGAL CREAM MAXIMUM STRENGTH 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-208
    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
    COTTONSEED OIL (UNII: H3E878020N)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-208-5050 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2022
    Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-208)
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