MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [NUCARE PHARMACEUTICALS,INC.]

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MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [NUCARE PHARMACEUTICALS,INC.]
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NDC 66267-980-15
Set ID 562dfc9f-1897-330a-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole USP 1% w/w

  • Purpose

    Antifungal Cream

  • Uses

    Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only.
    • Avoid contact with eyes.
    • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

    • Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of this 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 the 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.
    • If conditions persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Other information

    • Store at controlled room temperature 15°-30°C (59°-86°F).
    • Close cap tightly after use.
  • Inactive ingredients

    aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

  • Questions?

    Adverse Drug Event call (800)616-2471
    Dist. By MAJOR PHARMACEUTICALS
    31778 Enterprise Drive, Livonia, Ml 48150 USA
    Re-Oder No. 100431

  • Principal Display Panel – 1 oz. Tube

    pdp

  • INGREDIENTS AND APPEARANCE
    MAJOR CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-980(NDC:0904-7822)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66267-980-1514.17 g in 1 BOX; Type 0: Not a Combination Product08/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/04/2004
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(66267-980)
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