Label: TERRASIL FOOT AND NAIL ANTI-FUNGAL- clotrimazole cream

  • 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 June 26, 2014

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    Cures most athlete’s foot and toe area fungal infections. 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 2 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, call poison control or seek medical help.

  • 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

    bentonite clay, distilled water, eucalyptus citriodora oil, jojoba seed oil, silver oxide, tea tree oil, zinc oxide.


  • QUESTIONS

    Questions?401-432-7750 or www.Aidance.com

  • PRINCIPAL DISPLAY PANEL - 25g Bottle

    ALL NATURAL

    terrasil

    THE END OF SUFFERING SKIN

    FOOT & NAIL

    ANTI-FUNGAL

    CREAM

    Bottle Label Image

  • INGREDIENTS AND APPEARANCE
    TERRASIL FOOT AND NAIL ANTI-FUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-125-2525 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/26/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-125) , label(24909-125)
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