Label: ZEASORB AF- miconazole nitrate powder

  • Category: HUMAN OTC DRUG LABEL

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 May 23, 2012

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    antifungal

  • Use (Athlete's Foot)

    for the cure of most athlete's foot

  • Warnings

    For external use only

    Do not use

    • on children under 2 years of age unless directed by a doctor.

    Avoid contact with the eyes.

    Stop use and ask a doctor if (Athlete's Foot)

    • irritation occurs or there is no improvement within 4 weeks.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions (Athlete's Foot)

    • 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.
    • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • Use daily for 4 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Other information

    Product settles during shipment. Package contains full net weight.

  • Inactive ingredients

    acrylamide/sodium acrylate copolymer, aldioxa, chloroxylenol, fragrance, imidurea, microporous cellulose, talc. Contains no starch.

  • Questions?

    call 1-888-438-7426. Side effects should be reported to this number.

    Manufactured for: Stiefel Laboratories, Inc. Research Triangle Park, NC 27709

    www.zeasorb.com

    IRONMAN® is a registered trademark of World Triathlon Corporation used herein by permission.

    ZEASORB is a registered trademark of Stiefel Laboratories, Inc.



    Additional barcode labeling by:
    Physicians Total Care, inc.
    Tulsa, Oklahoma      74146

  • Principal Display Panel

    NDC 54868-5876-0

    Zeasorb Antifungal Treatment Athlete's foot 2.5 oz (71 g) front label

    Zeasorb®

    ANTIFUNGAL TREATMENT

    Miconazole Nitrate 2%

    Super Absorbent Powder

    cures most

    athlete's foot

    Relieves:

    • Itching
    • Burning
    • Scaling

    Official Partner IRONMAN®

    Net Wt. 2.5 Oz (71g)


  • INGREDIENTS AND APPEARANCE
    ZEASORB  AF
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5876(NDC:0145-1506)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLAMIDE (UNII: 20R035KLCI)  
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5876-071 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/31/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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