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Antifungal by Preferred Pharmaceuticals Inc.

Medically reviewed on December 14, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-7374

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 Cream, USP

Drug Facts

Active ingredient

Miconazole nitrate, USP 2%

Purpose

Antifungal

Uses
proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
for effective relief of itching, scaling, cracking, burning, and discomfort

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
there is no improvement within 4 weeks (for athlete's foot and 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
wash 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: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information
store at controlled room temperature 59°-86°F (15°-30°C).
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Actavis
NDC 68788-7374
Compare to the active ingredient in Micatin® Antifungal Cream 

Antifungal Cream
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning 

Cures Most Athlete’s Foot, Jock Itch & Ringworm 

Net wt. 0.5 oz (14g)

ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7374(NDC:0472-0735)
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 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68788-7374-21 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/25/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7374)

 
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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