MICONAZOLE CREAM [KINRAY, INC.]

MICONAZOLE CREAM [KINRAY, INC.]
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NDC 61715-050-01
Set ID a44c3b24-dae2-4993-a49f-71e4eb63b231
Category HUMAN OTC DRUG LABEL
Packager Kinray, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Miconazole Nitrate 2%

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  • Warnings

    For External Use Only

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  • DO NOT USE

    Do not use

    • on children under 2 years of age unless directed by a doctor.
    • for diaper rash

    When using this product 

    • avoid contact with eyes
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  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvementwithin 2 weeks when used for the treatment of jock itch
    • there is no improvementwithin 4 weeks when used for athletes foot or ringworm
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  • Uses

    • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch or itching burning feet
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  • Indications and Usage

    • Supervise children in the use of this product.
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  • Other information.

    Store at room temperature

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  • Directions

    • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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.
    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on scalp or nails.
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  • Inactive Ingredients

    Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

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  • Keep Out of Reach of Children

    • KEEP OUT OF REACH OF CHILDREN
    • If swallowed get medical help or contact a Poison Control Center right away
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Preferred Plus Pharmacy

    Miconazole Nitrate Cream USP 2%

    KR Miconazole.jpg

    KR Miconazole

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  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    miconazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-050
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-050-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 03/22/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/21/2013
    Labeler - Kinray, Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
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