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Antifungal by Actavis Mid Atlantic LLC

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Actavis Mid Atlantic LLC
NDC Code: 0472-0735

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 Antifungal Cream

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 section

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
  • do not use if seal on tube is punctured or is not visible
  • to puncture the seal, reverse the cap and place the puncture-top onto the tube. Push down firmly until seal is open. To close, screw the cap back onto the tube
  • 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

Compare to the active ingredient in Micatin® Antifungal Cream
NDC 0472-0735-14 

Actavis 

Antifungal Cream
Miconazole Nitrate Cream, USP 2%

Cures Most Athlete’s Foot,
Jock Itch & Ringworm
Soothes Itching, Scaling, Cracking, and Burning

 Net wt. 0.5 oz (14g)

  

ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0472-0735-141 TUBE in 1 CARTON
114 g in 1 TUBE
2NDC:0472-0735-561 TUBE in 1 CARTON
228 g in 1 TUBE
3NDC:0472-0735-421 TUBE in 1 CARTON
342.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C05/01/2007
Labeler - Actavis Mid Atlantic LLC (809515898)

Revised: 05/2014
 
Actavis Mid Atlantic LLC

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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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