MICONAZOLE- antifungal cream

MICONAZOLE by

Drug Labeling and Warnings

MICONAZOLE by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Priva Te Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MICONAZOLE 
antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-050-01	72 in 1 CASE
1		1 in 1 BOX
1		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/18/2013

Labeler - Galentic Pharma (India) Priva Te Limited (918531450)