ZEASORB- miconazole nitrate powder

Zeasorb by

Drug Labeling and Warnings

Zeasorb by is a Otc medication manufactured, distributed, or labeled by Stiefel Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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. Avoid open wounds.
• 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 below 25°C (77°F). Product settles during shipment. Package contains full net weight.

Inactive ingredients

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

Questions?

call 1-888-438-7426

Distributed by: Stiefel Laboratories, Inc., Research Triangle Park, NC 27709

Made in India

Trademarks are owned by or licensed to the GSK group of companies.

Principal Display Panel

NDC: 0145-1506-05

Super Absorbent Powder

Zeasorb® AF

ANTIFUNGAL TREATMENT

Miconazole Nitrate 2%

Super Absorbent Powder

cures most athlete's foot

Relieves:

• Itching
• Burning
• Scaling

#1 Dermatologist Recommended

Stiefel

Net wt. 2.5 OZ (71 g)

©2015 GSK or its licensor. All rights reserved.

Front Label: 103580XC

Principal Display Panel

NDC: 0145-1501-03

Super Absorbent Powder

Zeasorb® AF

ANTIFUNGAL TREATMENT

Miconazole Nitrate 2%

cures most jock itch

Relieves:

• Itching
• Burning
• Scaling

#1 Dermatologist Recommended

Stiefel

Net wt. 2.5 OZ (71 g)

©2015 GSK or its licensor. All rights reserved

Front Label: 103658XB

INGREDIENTS AND APPEARANCE

ZEASORB 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0145-1506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0145-1506-05	71 g in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2011	05/31/2020
2	NDC: 0145-1506-01	20 in 1 CARTON	03/14/2011	05/31/2020
2	NDC: 0145-1506-61	2.8 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/14/2011	05/31/2020

ZEASORB 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0145-1501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0145-1501-03	71 g in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2011	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/14/2011	05/31/2020

Labeler - Stiefel Laboratories Inc (808842343)