Label: ANTI-FUNGAL- miconazole nitrate cream

  • NDC Code(s): 52000-021-36, 52000-021-37
  • Packager: Universal Distribution Center LLC
  • 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 April 15, 2015

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  • 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 Hydroxyanisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Anti-Fungal Cream

    NET WT 0.5 OZ (14 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-021
    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:52000-021-371 in 1 BOX
    1NDC:52000-021-3614 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-021)