ANTIFUNGAL CREAM- 2% miconazole nitrate cream cream

Antifungal Cream by

Drug Labeling and Warnings

Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

• For external use only
• Avoid contact with eyes
• Keep out of reach of children
• If swallowed, get medical help or contact Poison Control Center right away
• For athlete's foot and ringworm, if irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a physician
• For jock itch, if irritation occurs or there is no improvement within 2 weeks, discontinue use and consult a physician
• Do not use on deep or puncture wounds, animal bites, serious burns, for diaper rash, on children younger tha 2 years of age.

Active Ingredients

Miconazole Nitrate 2%       Antifungal

Uses

A clinically effective treatment for:

• most athlete's foot (tinea pedis)
• jock itch (tinea cruris)
• ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Uses

A clinically effective treatment for:

most athlete's foot (tinea pedis)jock itch (tinea cruris)ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Directions

• Glently cleanse the treatment area
• Pat dry
• Apply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physician
• For athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once daily
• Use daily for 4 weeks for treatment of athlete's foot and ringworm
• Use daily for 2 weeks for treamnet of jock itch
• If condition persists longer, consult a physician
• This product is not effective on the scalp or nails

Directions

Glently cleanse the treatment areaPat dryApply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physicianFor athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once dailyUse daily for 4 weeks for treatment of athlete's foot and ringwormUse daily for 2 weeks for treamnet of jock itchIf condition persists longer, consult a physicianThis product is not effective on the scalp or nails

Other Information

Store between 15-30oC (59-86oF)

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

Allantoin, beeswax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, fragrance, hydrogenated castor oil, isopropyl palmitate, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium chloride, zinc oxide

labeling

INGREDIENTS AND APPEARANCE

ANTIFUNGAL CREAM 
2% miconazole nitrate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE 1000 (UNII: MCU2324216)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WHITE WAX (UNII: 7G1J5DA97F)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ZINC OXIDE (UNII: SOI2LOH54Z)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-009-04	120 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2015

Labeler - Cardinal Health (097537435)