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MICONAZOLE by Kinray, Inc.

Medically reviewed on June 22, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Kinray, Inc.
NDC Code: 61715-050

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%

Warnings

For External Use Only

Do not use

  • on children under 2 years of age unless directed by a doctor.
  • for diaper rash

When using this product 

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvementwithin 2 weeks when used for the treatment of jock itch
  • there is no improvementwithin 4 weeks when used for athletes foot or ringworm

Uses
  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch or itching burning feet

Indications and Usage
  • Supervise children in the use of this product.

Other information.

Store at room temperature

Directions
  • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 toes: wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Foe athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on scalp or nails.

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 right away

Principal Display Panel

Preferred Plus Pharmacy

Miconazole Nitrate Cream USP 2%

KR Miconazole.jpg

MICONAZOLE 
miconazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-050
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:61715-050-0128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/21/2013
Labeler - Kinray, Inc. (012574513)
Registrant - Dynarex Corporation (008124539)

 
Kinray, 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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