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

TERRASIL TINEA TREATMENT MAX (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-104-14, 24909-104-15, 24909-104-44, 24909-104-50
Set ID d0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa
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

    Clears up tinea fungal infections including tinea corporis, tinea cruris, tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness an 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 ointment 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), cottonseed oil, bentonite (volcanic clay), cedarwood oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, stearic acid, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    All Natural

    terrasil®
    TINEA TREATMENT
    MAXIMUM STRENGTH
    with Activated Minerals®

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL TINEA TREATMENT  MAX
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-104
    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)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-104-1414 g in 1 JAR; Type 0: Not a Combination Product05/12/2014
    2NDC:24909-104-4444 g in 1 JAR; Type 0: Not a Combination Product05/12/2014
    3NDC:24909-104-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    4NDC:24909-104-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/12/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-104) , label(24909-104)

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