TERRASIL ANTI-FUNGAL TREATMENT MAX (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

TERRASIL ANTI-FUNGAL TREATMENT MAX (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-106-14, 24909-106-15, 24909-106-20, 24909-106-44, 24909-106-50
Set ID db356cc8-f473-4eb2-b8d8-72606fca9dc0
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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 Terrasil 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.

  • Inactive Ingredients

    beeswax (organic), bentonite, cottonseed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    All Natural
    terrasil
    ANTI-FUNGAL TREATMENT
    MAXIMUM STRENGTH
    with Activated Minerals®

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL ANTI-FUNGAL TREATMENT  MAX
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-106
    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:24909-106-1414 g in 1 JAR; Type 0: Not a Combination Product09/07/2012
    2NDC:24909-106-4444 g in 1 JAR; Type 0: Not a Combination Product09/07/2012
    3NDC:24909-106-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    4NDC:24909-106-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    5NDC:24909-106-20200 g in 1 JAR; Type 0: Not a Combination Product02/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-106) , label(24909-106)

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