ZEASORB AF (MICONAZOLE NITRATE) POWDER [PHYSICIANS TOTAL CARE, INC.]

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ZEASORB AF (MICONAZOLE NITRATE) POWDER [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-5876-0
Set ID 3c6e29fe-3e37-458c-a237-4034513a459f
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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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