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  5. Label Information: Zeasorb

FDA Label for Zeasorb

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE (ATHLETE'S FOOT)
    4. USE (JOCK ITCH)
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF (ATHLETE'S FOOT)
    8. STOP USE AND ASK A DOCTOR IF (JOCK ITCH)
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS (ATHLETE'S FOOT)
    11. DIRECTIONS (JOCK ITCH)
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL

Zeasorb Product Label

The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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. Made in India


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

    NDC 03016-0232-25

    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


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