Label: TERRASIL FOOT AND NAIL ANTI-FUNGAL MAXIMUM STRENGTH- clotrimazole ointment

  • 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 December 29, 2018

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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.

  • KEEP OUT OF REACH OF CHILDREN

  • 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.

  • 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

    beeswax (organic), cotton seed oil, bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL - 25g Tube

    ALL NATURAL

    terrasil

    MAX Strength

    FOOT & NAIL

    ANTI-FUNGAL OINTMENT

    with Activated Minerals®

    Tube Image

  • INGREDIENTS AND APPEARANCE
    TERRASIL FOOT AND NAIL ANTI-FUNGAL  MAXIMUM STRENGTH
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-126
    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)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-126-2525 g in 1 TUBE; Type 0: Not a Combination Product06/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/27/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-126) , label(24909-126)
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