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MICONAZOLE by Galentic Pharma (India) Priva Te Limited

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Galentic Pharma (India) Priva Te Limited
NDC Code: 50382-050

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.

Antifungal

Active Ingredient

Miconazole Nitrate 2%

Uses - Antifungal
  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Supervise children in the use of this product.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.

Other information.

Protect from freezing. Avoid excessive heat.

Directions
  • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
  • Foe athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Keep Out of Reach of Children
  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed get medical help or contact a Poison Control Center.

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%


Gal Miconazole.jpg

MICONAZOLE 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-050
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
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
LIGHT MINERAL OIL 
PROPYLENE GLYCOL 
WATER 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:50382-050-0172 BOX (BOX) in 1 CASE
11 TUBE (TUBE) in 1 BOX
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/18/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

 
Galentic Pharma (India) Priva Te Limited

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Medically reviewed on Jul 23, 2018

Further information

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

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