BUDPAK ANTIFUNGAL MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [BUDPAK INC. ]

BUDPAK ANTIFUNGAL MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [BUDPAK INC. ]
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NDC 27293-023-01, 27293-023-14
Set ID 1a156ca6-b290-4ab8-9efa-1ceebeabf7c2
Category HUMAN OTC DRUG LABEL
Packager Budpak Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active Ingredient

    Miconazole Nitrate 2.0%

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • cures most athlete's foot, jock itch, and ringworm.
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
  • WARNINGS

    Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    Stop using this product and ask a doctor

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
    • do not use for diaper rash
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • wash affected area and dry thoroughly

    • Apply a thin layer 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 the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day

    • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

    • if conditions persist longer, ask a doctor

    • this product is not effective on the scalp or nails.

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store between 15ºC to 30º C (59ºF to 86º F)
    • Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Budpak Antifungal Cream

    Miconazole Nitrate 2%

    Antifungal for Athlete’s Foot and Jock Itch

    NET WT 0.5 OZ (14 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK ANTIFUNGAL MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-5 OLEATE (UNII: 0240V77G50)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-023-011 in 1 BOX
    1NDC:27293-023-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/29/2013
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-023)

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