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Miconazole Nitrate by Aru Pharma Inc.

Medically reviewed on February 23, 2018

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Aru Pharma Inc.
NDC Code: 70403-924

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.

QPACK MICONAZOLE NITRATE CREAM 2%

Drug Facts

Active ingredient

Miconazole Nitrate USP 2%

Purpose

Antifungal

Uses
  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

Warnings

For external use only
Do not use on children less than 2 years of age unless directed by a doctor
When using this product avoid contact with eyes
Stop use and ask a doctor if • irritation occurs • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
  • 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
  • not effective on the scalp or nails

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

Other information

• Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30​°​C (86​°​F). Do not freeze. • see carton or tube crimp for lot number and expiration date

Questions or comments?

1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

CURES MOST ATHLETE'S FOOT

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

Compared to the active ingredient in Micatin

Distributed by.

ARU PHARMA INC.
MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-924
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
CETOSTEARYL ALCOHOL 
CETETH-20 
PARAFFIN 
MICROCRYSTALLINE WAX 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
CHLOROCRESOL 
WATER 
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70403-924-301 TUBE in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2018
Labeler - Aru Pharma Inc. (079736192)

 
Aru Pharma Inc.

← See all Miconazole Nitrate brands

Further information

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

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