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Miconazole Nitrate by Physicians Total Care, Inc.

Medically reviewed on Nov 6, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-2471

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 54868-2471-0


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. 14 g  tube cream

07350200D1 VC106266






Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2471(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:54868-2471-01 TUBE (TUBE) in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C03/20/2012
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel(54868-2471)

 
Physicians Total Care, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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