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Miconazole Nitrate by Preferred Pharmaceuticals, Inc.

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-0344

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.

Miconazole Nitrate 2% Cream

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses
proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, scaling, cracking, burning and discomfort associated with those conditions

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if
irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
irritation occurs or if there is no improvement 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 the product over affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product

For athlete's foot:

use daily for 4 weeks. If condition persists longer, consult a doctor.
pay special attention to the spaces between the toes
wear well-fitting, ventilated shoes
change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Other information
store at 15° - 30°C (59° - 86°F)
lot number and expiration date: see crimp of tube or see box
to open: unscrew cap, use pointed end on cap to puncture seal

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R2
8280719 7805

Repackaged by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0344(NDC:0603-7805)
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
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68788-0344-21 TUBE in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/02/2014
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-0344)

Revised: 12/2016
 
Preferred Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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