FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]

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FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]
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NDC 0884-0293-01
Set ID 250d0a66-01d1-4aba-8f24-4cb4ca529fda
Category HUMAN OTC DRUG LABEL
Packager Pedinol Pharmacal, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate 2% USP

  • Purpose

    Antifungal

  • Uses

    •
    cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    •
    for effective relief of itchy, scaly skin between the toes
  • Warnings

    For external use only

    Flammable:

    Do not use while smoking or near heat or flame.

    Do not use

    on children under 2 years of age unless directed by a doctor.

    When using this product

    •
    avoid contact with the eyes.
    •
    if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Keep out of reach of children.

    If swallowed, get 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 affected area twice daily (morning and night) or as directed by a doctor
    •
    supervise children in the use of this product
    •
    for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    •
    for athlete’s foot and ringworm, use daily for 4 weeks
    •
    if condition persists longer, consult a doctor
    •
    this product is not effective on scalp or nails.
  • Other information

    •
    store at controlled room temperature 15-30oC (59-86oF)
  • Inactive ingredients

    acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

  • Questions or comments?

    1-800-321-4576

  • Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton

    NDC 0884-0293-01

    PEDiNOL®

    fungoid® tincture

    miconazole nitrate 2%

    topical antifungal

    1 fl. oz. (29.57 mL)

    Pedinol carton
  • INGREDIENTS AND APPEARANCE
    FUNGOID TINCTURE 
    miconazole nitrate tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-0293
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Acetic Acid (UNII: Q40Q9N063P)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Laureth-4 (UNII: 6HQ855798J)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0884-0293-011 in 1 CARTON04/11/2012
    129.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/11/2012
    Labeler - Pedinol Pharmacal, Inc. (064737125)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Acquisition Corp.048602791MANUFACTURE(0884-0293)
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