ANTIFUNGAL- miconazole nitrate cream

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by PSS World Medical, Inc., Zhejiang Medicare Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

​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

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
miconazole nitrate cream

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

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

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

Labeler - PSS World Medical, Inc. (101822682)

Registrant - PSS World Medical, Inc. (101822682)

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