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Antifungal by PSS World Medical, Inc.

Medically reviewed on September 27, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: PSS World Medical, Inc.
NDC Code: 68345-817

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Antifungal Cream

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

ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-817
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
MAGNESIUM ALUMINUM SILICATE 
PETROLATUM 
PROPYLPARABEN 
POLYOXYL 40 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68345-817-25142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/05/2012
Labeler - PSS World Medical, Inc. (101822682)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIOperations
Zhejiang Medicare Pharmaceutical Co., Ltd.421293835manufacture(68345-817)

 
PSS World Medical, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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