← See all Antifungal Cream brands

Antifungal Cream 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 2%

PURPOSE

Antifungal

USES
  • treats most athlete’s foot, jock itch and ringworm
  • relieves itching, scaling, burning, irritation and discomfort

WARNINGS

For external use only

WHEN USING THIS PRODUCT
  • do not get into the eyes

STOP USE AND ASK A DOCTOR IF
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

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

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
  • this product does not work on the scalp or nails

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 every day

    For athlete’s foot and ringworm

  • use every day for 4 weeks

    For jock itch

  • use every day for 2 weeks. If condition lasts longer, contact a doctor.

OTHER INFORMATION

Store at room temperature 59º - 86ºF (15º - 30ºC).

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

INACTIVE INGREDIENTS

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0735-42

Compare to the active ingredient in Micatin® Antifungal Cream*

Actavis

Antifungal Cream

Miconazole Nitrate 2%

Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

Net wt. 42.5 g (1.5 oz) cream

07350200D1 VC106266

Carton Label

ANTIFUNGAL CREAM 
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 
WATER 
Packaging
#Item CodePackage Description
1NDC:0472-0735-141 TUBE (TUBE) in 1 CARTON
114 g in 1 TUBE
2NDC:0472-0735-561 TUBE (TUBE) in 1 CARTON
228 g in 1 TUBE
3NDC:0472-0735-421 TUBE (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)
Establishment
NameAddressID/FEIOperations
Actavis Mid Atlantic LLC809515898MANUFACTURE(0472-0735)

Revised: 08/2012
 
Actavis Mid Atlantic LLC

← See all Antifungal Cream brands

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.

Hide
(web2)