MITRAZOL ANTIFUNGAL

Dosage form: powder
Ingredients: MICONAZOLE NITRATE 0.02g in 1g
Labeler: HEALTHPOINT, LTD
NDC Code: 0064-0650

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.

MITRAZOL® ANTIFUNGAL POWDER – miconazole nitrate powder

Drug Facts

Active Ingredient

Miconazole Nitrate, 2%

Purpose

Antifungal

Uses

For the cure of athlete’s foot (dermatophytosis), jock itch (tinea cruris), and ringworm (tinea corporis).  Soothes chafing associated with jock itch, itching and burning.

Warnings
  • For external use only.
  • Avoid contact with the eyes.
  • Do not use on children under 2 years of age except under the advice and supervision of a physician.
  • If irritation occurs or if there is no improvement within 2 weeks (for jock itch) or 4 weeks (for athlete’s foot or ringworm), discontinue use and consult a physician.

KEEP OUT OF REACH OF CHILDREN
  • Keep this and all drugs out of the reach of children.

Direction

Cleanse the skin with soap and water and dry thoroughly.  Apply a light dusting of Mitrazol Powder over affected area morning and night or as directed by physician.  For athlete’s foot, pay special attention to the spaces between the toes.  It is also helpful to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily.  Best results in athlete’s foot and ringworm are usually obtained within 4 weeks’ use of this product, and in jock itch, within 2 weeks’ use.  If satisfactory results have not occurred within these times, consult a physician.  Children under 12 years of age should be supervised in the use of this product.  This product is not effective on the scalp or nails.

Inactive Ingredients

Topical Starch USP, Tribasic Calcium Phosphate NF.

Questions?

Please call 1-800-441-8227 or visit our web site www.healthpoint.com.

PRINCIPAL DISPLAY PANEL

MITRAZOL® POWDER

(Miconazole Nitrate, 2%)

NDC 0064-0650-01

ANTIFUNGAL

NET WT. 1 OZ.

Additional information inside label.

Distributed by:
Healthpoint, Ltd.
San Antonio, Texas 78215         1-800-441-8227
REORDER NO. 0650-01            127567-0502

MITRAZOL  ANTIFUNGAL
mitrazol nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-0650
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TRIBASIC CALCIUM PHOSPHATE 
Product Characteristics
ColorWHITE (OFF-WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0064-0650-0128 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/01/2001
Labeler - HEALTHPOINT, LTD (965634504)
Establishment
NameAddressID/FEIOperations
DPT LABORATORIES, LTD832224526MANUFACTURE

Revised: 11/2010
 
HEALTHPOINT, LTD

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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