MICONAZOLE NITRATE CREAM [RUGBY LABORATORIES, INC.]

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MICONAZOLE NITRATE CREAM [RUGBY LABORATORIES, INC.]
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NDC 0536-1134-28
Set ID 34198e9c-4856-4ba0-b78b-9c3b28baff0d
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    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, 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 persists
    • 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. 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
  • Other information

    • do not use if the seal on tube is punctured or not visible
    • To open: unscrew cap, use pointed end on cap to puncture seal
    • store at 20° - 25°C (68° - 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by: RUGBY LABORATORIES
    17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    Rugby

    Antifungal Cream

    Cures Most Athlete's Foot
    Miconazole Nitrate

    Cream USP, 2%
    Antifungal Cream

    NET WT 1 oz (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1134
    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
    apricot kernel oil (UNII: 54JB35T06A)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    glycol stearate (UNII: 0324G66D0E)  
    mineral oil (UNII: T5L8T28FGP)  
    polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
    water (UNII: 059QF0KO0R)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1134-281 in 1 CARTON05/19/2017
    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 FINALpart333C10/01/1991
    Labeler - Rugby Laboratories, Inc. (079246066)
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