SILKA ANTIFUNGAL FOOT (MICONAZOLE NITRATE) POWDER [GENOMMA LAB]

SILKA ANTIFUNGAL FOOT (MICONAZOLE NITRATE) POWDER [GENOMMA LAB]
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NDC 50066-028-03
Set ID 7fac661e-403c-ae81-e053-2991aa0accd2
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    For the cure of most athlete's foot.

  • Warnings

    For external use only.

    Do not use on children of 2 years of age unless directed by a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

  • Keep Out of Reach of Children.

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
    • Supervise children in the use of this product.
    • Pay special attention to space between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
    • Use daily for 4 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on scalp and nails.

  • Inactive Ingredients

    Aldioxa, Cellulose, Chloroxylenol, Fragrance, Imidazolidynl Urea, Talc.

  • PRINCIPAL DISPLAY PANEL

    Front LabelBack Label

  • INGREDIENTS AND APPEARANCE
    SILKA ANTIFUNGAL FOOT 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA CELLULOSE (UNII: I355QGZ19A)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    TALC (UNII: 7SEV7J4R1U)  
    ALDIOXA (UNII: 8T66I31YNK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-028-0385 g in 1 BOTTLE; Type 0: Not a Combination Product08/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/09/2018
    Labeler - Genomma Lab (832323534)
    Registrant - CGI Packaging, LLC (080691099)
    Establishment
    NameAddressID/FEIBusiness Operations
    CGI Packaging, LLC080691099manufacture(50066-028)

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