Label: ALEVAZOL- clotrimazole ointment

  • NDC Code(s): 29978-918-60
  • Packager: Capital Pharmaceutical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 18, 2014

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  • SPL UNCLASSIFIED SECTION

    Alevazol Drug Facts

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  • Active Ingredient

    Clotrimazole

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  • Purpose

    Antifungal

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  • Uses

    • Clears up most tinea cruris, candida albicans or tinea corporis.
    • For effective relief of itching, scaling, cracking, burning, redness, soreness & irritation.
    • For discomfort, scaly skin between the toes or burning feet.
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  • Warning.

    • For external use only.
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  • When Using This Product

    • Avoid contact with eyes.
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  • Stop Use and Ask a Doctor if.

    • Irritation occurs
    • There is no improvement within 4 weeks (for athletes foot and ringworm) or within 2 weeks (for jock itch)
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  • Keep out of reach of children.

    • If swallowed get medical help or contact a Poison Control Center right away.
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  • 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 and ringworm: use daily for 4 weeks.
    • For Candida Albicans use daily for 2 weeks.
    • For athletes foot: Pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least one daily.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails

    Other Information.

    • Store at 15deg –30deg C (59deg-86deg F)
    • Lot No and Exp Date: See Crimp of tube.
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  • Inactive Ingredients.

    • Aloe Vera Gel, Ceresin Wax, Dried Aluminum Hydroxide Gel USP (for Coloring), Lanolin USP, Mineral Oil USP, Snow White PET-G USP.
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  • Question? Comments?

    • Call 1-(614) 638-4622
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  • PRINCIPAL DISPLAY PANEL

    Alevazol with ACTIVEaloe®
    CLOTRIMAZOLE 1% OINTMENT
    ANTIFUNGAL

    PRINCIPAL DISPLAY PANEL
Alevazol with ACTIVEaloe®
CLOTRIMAZOLE 1% OINTMENT
ANTIFUNGAL

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  • INGREDIENTS AND APPEARANCE
    ALEVAZOL 
    clotrimazole ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29978-918
    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
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29978-918-60 1 in 1 CARTON
    1 56.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 09/01/2014
    Labeler - Capital Pharmaceutical, LLC (831545541)
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