Label: ZEASORB- miconazole nitrate powder

  • NDC Code(s): 0316-0231-25, 0316-0232-25
  • Packager: Crown Laboratories
  • 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 February 21, 2022

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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, Croscarmellose Sodium, Fragrance, Imidazolidinyl Urea, Magnesium Stearate, Microcrystalline Cellulose, Sodium Acrylates Crosspolymer-2

  • Questions or comments?

    call 1-833-279-6522

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

    ZEASORB is a registered trademark of Crown Laboratories, Inc.

    P11552.01 ©2020 Crown Laboratories, Inc.

  • Principal Display Panel

    NDC 0316-0231-25

    Zeasorb ® AF

    ANTIFUNGAL TREATMENT

    Miconazole Nitrate 2%

    Super Absorbent Powder

    New & Improved

    cures most athlete's foot

    Absorbs & Repels Moisture

    Relieves:

    • Itching
    • Burning
    • Scaling

    Dermatologist Recommended

    Net wt. 2.5 oz (71 g)

    Front Label: P11546.01

    athlete's foot

  • Principal Display Panel

    NDC 0316-0232-25

    Zeasorb ® AF

    ANTIFUNGAL TREATMENT

    Miconazole Nitrate 2%

    Super Absorbent Powder

    New & Improved

    cures most jock itch

    Absorbs & Repels Moisture

    Relieves:

    • Itching
    • Burning
    • Scaling

    Dermatologist Recommended

    Net wt. 2.5 oz (71 g)

    Front Label: P11551.01

    jock itch

  • 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 ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    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
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    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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