MICONAZOLE (ANTIFUNGAL) CREAM [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]

MICONAZOLE (ANTIFUNGAL) CREAM [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]
PDF | XML

NDC 50382-050-01
Set ID 853f5d10-99c3-4fdc-87b9-0ee6826e84ad
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Priva Te Limited
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-050-0172 in 1 CASE
    11 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)

Related Drugs