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Major Clotrimazole (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (0904-7822-36) > 14.17 g in 1 TUBE Label Information
CREAM 1 TUBE in 1 CARTON (0904-7822-31) > 28.35 g in 1 TUBE Label Information

Complete Major Clotrimazole Information

  • 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

    MAJOR® NDC 0904-7822-31

    CLOTRIMAZOLE ANTI-FUNGAL CREAM

    CREAM USP, 1%

    Cures Most Athlete's Foot NET WT. 28.35 g (1 oz)

    Principal Display Panel – 1 oz. Tube

  • Principal Display Panel – 1 oz. Carton

    MAJOR® NDC 0904-7822-31

    Cures Most

    Athlete's Foot

    Relieves Itching, Burning, Greaseless, Nonstaining

    CLOTRIMAZOLE ANTI-FUNGAL CREAM

    CREAM USP, 1%

    *Compare To the active ingredient in Lotrimin-AF® NET WT. 28.35 g (1 oz)

    Principal Display Panel – 1 oz. Carton

  • INGREDIENTS AND APPEARANCE
    MAJOR CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7822
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-7822-31 1 in 1 CARTON
    1 28.35 g in 1 TUBE
    2 NDC:0904-7822-36 1 in 1 CARTON
    2 14.17 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 10/04/2004
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
    Establishment
    Name Address ID/FEI Business Operations
    Faria LLC dba Sheffield Pharmaceuticals 151177797 MANUFACTURE(0904-7822)