ZEASORB- miconazole nitrate powder

Zeasorb by

Drug Labeling and Warnings

Zeasorb by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. 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. 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

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

INGREDIENTS AND APPEARANCE

ZEASORB 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
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: 0316-0232-25	71 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018

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

ZEASORB 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
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: 0316-0231-25	71 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018

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

Labeler - Crown Laboratories (079035945)