MICONAZOLE NITRATE CREAM [ARU PHARMA INC.]

MICONAZOLE NITRATE CREAM [ARU PHARMA INC.]
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NDC 70403-924-30
Set ID 0eecb20d-49bc-4186-ac29-f839536b5de2
Category HUMAN OTC DRUG LABEL
Packager Aru Pharma Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Drug Facts

  • Active ingredient

    Miconazole Nitrate USP 2%

  • Purpose

    Antifungal

  • Uses

    • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • for effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.
  • Warnings

    For external use only
    Do not use on children less than 2 years of age unless directed by a doctor
    When using this product avoid contact with eyes
    Stop use and ask a doctor if • irritation occurs • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

  • 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 (1-800-222-1222).

  • 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 the 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.
    • For jock itch: use daily for 2 weeks
    • not effective on the scalp or nails
  • Inactive ingredients

    Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

  • Other information

    • Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30​°​C (86​°​F). Do not freeze. • see carton or tube crimp for lot number and expiration date

  • Questions or comments?

    1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

  • SPL UNCLASSIFIED SECTION

    CURES MOST ATHLETE'S FOOT

    Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

    Compared to the active ingredient in Micatin

    Distributed by.

    ARU PHARMA INC.
    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Micnzle1

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70403-924-301 in 1 CARTON01/01/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2018
    Labeler - Aru Pharma Inc. (079736192)

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