Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Treats jock itch, ringworm, and athlete's foot.

INDICATIONS: Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.

Warnings

For external use only.

PRECAUTIONS: For external use only. Not intended for ingestion. Avoid contact with eyes.

Do not use

Do not use on children under 2 years of age unless directed by a doctor.

Stop use and ask a doctor if

irritation develops
there is no improvement within 4 weeks for athlete's foot or ringworm
or within 2 weeks for jock itch

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.

Directions

clean the affected area and dry thoroughly
apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
supervise children in the use of this product

Athlete's Foot

pay special attention to the spaces between toes
wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete's Foot and Ringworm

use daily for 4 weeks

Jock Itch

use daily for 2 weeks

This product is not effective on scalp or nails.

Inactive Ingredients

BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.

Questions

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in China

Storage

Store at room temperature 15-30C (59-86F).

Package Label

NDC 68345-817-25

6391 Each

6391 Box

ANTIFUNGAL
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68345-817
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68345-817-25	142 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/05/2012

Labeler - PSS World Medical, Inc. (101822682)

Registrant - PSS World Medical, Inc. (101822682)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Medicare Pharmaceutical Co., Ltd.		421293835	manufacture(68345-817)

Antifungal Cream