ZEASORB (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]

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ZEASORB (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]
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NDC 0316-0231-25, 0316-0232-25
Set ID 7b303360-cbca-8233-e053-2991aa0a902f
Category HUMAN OTC DRUG LABEL
Packager Crown Laboratories
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

  • Use (Jock Itch)

    for the cure of most jock itch

  • Warnings

    For external use only. Avoid contact with the eyes.

    Do not use

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

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

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

    Stop use and ask a doctor if (Jock Itch)

    • irritation occurs or there is no improvement within 2 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
  • Directions (Jock Itch)

    • 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
    • use daily for 2 weeks
    • if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

    Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

    Product settles during shipment. Package contains full net weight.

  • Inactive ingredients

    aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, sodium polyacrlate, talc

  • Questions?

    call 1-833-279-6522

    Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

    ZEASORB is a registered trademark of Crown Laboratories, Inc.

    P11552 ©2018 Crown Laboratories, Inc.

  • Principal Display Panel

    NDC 0316-0231-25

    Zeasorb ® AF

    ANTIFUNGAL TREATMENT

    Miconazole Nitrate 2%

    Super Absorbent Powder

    cures most athlete's foot

    Relieves:

    • Itching
    • Burning
    • Scaling

    Net wt. 2.5 oz (71 g)

    Front Label: P11546

    p1154600

  • Principal Display Panel

    NDC 0316-0232-25

    Zeasorb ® AF

    ANTIFUNGAL TREATMENT

    Miconazole Nitrate 2%

    Super Absorbent Powder

    cures most jock itch

    Relieves:

    • Itching
    • Burning
    • Scaling

    Net wt. 2.5 oz (71 g)

    Front Label: P11551

    p1155100

  • INGREDIENTS AND APPEARANCE
    ZEASORB 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    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:0316-0232-2571 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/14/2011
    ZEASORB 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    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:0316-0231-2571 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/14/2011
    Labeler - Crown Laboratories (079035945)
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