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Antifungal

PSS World Medical, Inc.
PSS World Medical, Inc.

Antifungal Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

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

Antifungal

6391 Box

Antifungal

Antifungal

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68345-817
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CETOSTEARYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
METHYLPARABEN
magnesium aluminum silicate
petrolatum
PROPYLPARABEN
POLYOXYL 40 STEARATE
water

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-09-05


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Be sure to consult your doctor before taking any medication!
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