FASTRIN ANTI - FUNGAL SKIN CARE (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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FASTRIN ANTI - FUNGAL SKIN CARE (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-601-10, 24909-601-50
Set ID 40498493-2176-4ab5-8966-8119a44d3293
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Clean 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.

  • Inactive Ingredients

    Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    Fastrin

    Anti - Fungal

    Skin Care Ointment

    Net WT 50g (1.76 oz.)

    Tube Label

  • INGREDIENTS AND APPEARANCE
    FASTRIN ANTI - FUNGAL SKIN CARE 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-601
    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
    COTTONSEED OIL (UNII: H3E878020N)  
    HONEY (UNII: Y9H1V576FH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-601-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
    2NDC:24909-601-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-601) , label(24909-601)
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