Label: BOA VIDA ANTIFUNGAL- miconazole nitrate cream

  • 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 October 18, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients

    Miconazole Nitrate 2%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    Treats most jock itch, ringworm and athlete's foot

  • WARNINGS

    Warnings

    For external use only.

    Do not use on children under 2 years of age for diaper rash.

    Keep out of reach of children.

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

    If irritation occurs or if there is no improvement withing 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch, discontinue use and consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions

    Cleanse the affected area and dry thoroughly.

    Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product.

    Athlete's foot

    Pay special attention to the spaces between toes

    wear well-fitting, ventilated shoes and change shoes and socks at least once daily

    Athlete's foot and ringworm

    use daily for 4 weeks

    Jock Itch

    use daily for 2 weeks. If condition persists longer, consult a doctor.

    This product is not effective on scalp or nails.


  • STORAGE AND HANDLING

    Other Information

    Store at 59-86 F (15-30 C)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Isopropyl Palmitate, Polyquaternium-37, Propylene Glycol Dicaprylate Dicaprate, PPG-1 Trideceth-6, Propylene Glycol, Purified Water, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    BOA

    VIDA

    Antifungal

    Cream

    Relieves itching and

    burning discomfort associated

    with most jock itch, ringworm,

    and athlete's foot

    4 oz. (113g)

    container label

  • INGREDIENTS AND APPEARANCE
    BOA VIDA ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-147
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-147-01113 g in 1 TUBE; Type 0: Not a Combination Product09/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/10/2018
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-147)
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