drug facts

drug facts

SPL v1

SPL

SPL Set ID 3c6e29fe-3e37-458c-a237-4034513a459f

Route

topical

Published

Effective Date 2012-05-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

miconazole (20.6 mg)

Inactive Ingredients

acrylamide aldioxa chloroxylenol imidurea powdered cellulose talc

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2008-03-31

Purpose

antifungal

Description

Miconazole nitrate 2%

Medication Information

Warnings

For external use only

Purpose

antifungal

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.

Description

Miconazole nitrate 2%

Principal Display Panel

NDC 54868-5876-0

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)

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

Do Not Use

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

Avoid contact with the eyes.

Active Ingredient

Miconazole nitrate 2%

Use (athlete's Foot)

for the cure of most athlete's foot

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.

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If (athlete's Foot)

irritation occurs or there is no improvement within 4 weeks.

Structured Label Content

Warnings

For external use only

Purpose

antifungal

Other Information (Other information)

Product settles during shipment. Package contains full net weight.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

NDC 54868-5876-0

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)

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

Do Not Use (Do not use)

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

Avoid contact with the eyes.

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Use (athlete's Foot) (Use (Athlete's Foot))

for the cure of most athlete's foot

Directions (athlete's Foot) (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor If (athlete's Foot) (Stop use and ask a doctor if (Athlete's Foot))

irritation occurs or there is no improvement within 4 weeks.

Advanced Ingredient Data

[{"name": "MICONAZOLE", "unii": "7NNO0D7S5M", "classCode": "ACTIB", "strengthNumerator": "20.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ACRYLAMIDE", "unii": "20R035KLCI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALDIOXA", "unii": "8T66I31YNK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Purpose": "antifungal", "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.", "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", "Active ingredient": "Miconazole nitrate 2%", "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.", "Use (Athlete's Foot)": "for the cure of most athlete's foot", "Principal Display Panel": "NDC 54868-5876-0 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)", "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.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Stop use and ask a doctor if (Athlete's Foot)": "irritation occurs or there is no improvement within 4 weeks."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:28.531290 · Updated: 2026-03-14T22:53:08.969860