Label: FUNGOID TINCTURE- miconazole nitrate tincture

  • NDC Code(s): 0884-0293-01
  • Packager: Pedinol Pharmacal, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 18, 2020

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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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