Drug Facts

SELECT MEDICAL PRODUCTS ANTIFUNGAL- miconazole nitrate cream 
PSS WORLD MEDICAL, INC.

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.

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Drug Facts

Purpose:

Antifungal

Active ingredients:

Miconazole Nitrate 2%

Uses:

Treat jock itch, ringworm and athlete’s foot.

Warnings:

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

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if
■ irritation develops
■ there is no improvement within 4 week for athlete’s foot or ringworm
■ or within 2 weeks for jock itch.

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 ares 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.

Store at 15℃ to 30℃ (59℉ to 86℉).

For external use only.

Inactive ingredients:

Arlacel 165, BHT, Cod Liver Oil, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Lanolin, Liquid Paraffin, Methyparaben, Peregal O, Petrolatum, Propylparaben, Purified Water, Zinc Oxide.

Comments or Questions about Select Medical Products? 800-777-4908

Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in China •www.myselectonline.com

Principal Display Panel - 5oz Tube

NDC 68345-816-25

Select Medical Products®

Antifungal Cream
2%  Miconazole Nitrate

• Indicated for the treatment of jack itch ,ringworm and athlete’s foot

Store at 15℃ to 30℃ (59℉ to 86℉).

Comments or Questions about Select Medical Products? 800-777-4908.
Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in China   •www.myselectonline.com

NET WT. 5 oz. (142 g)
Reorder # 6390

6390 Tube Label Image here

SELECT MEDICAL PRODUCTS ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68345-816
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
POLYOXYL 100 STEARATE 
BUTYLATED HYDROXYTOLUENE 
COD LIVER OIL 
EDETATE DISODIUM 
.BETA.-CITRONELLOL, ()- 
GLYCERIN 
GLYCERYL MONOSTEARATE 
LANOLIN 
MINERAL OIL 
METHYLPARABEN 
POLYOXYL 20 CETOSTEARYL ETHER 
PETROLATUM 
PROPYLPARABEN 
WATER 
ZINC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68345-816-25142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/201003/31/2014
Labeler - PSS WORLD MEDICAL, INC. (101822682)

Revised: 12/2012
 
PSS WORLD MEDICAL, INC.