MICONAZOLE NITRATE CREAM USP, 2% cream

Miconazole Nitrate Cream USP, 2% by

Drug Labeling and Warnings

Miconazole Nitrate Cream USP, 2% by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

• For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

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 the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks when used for the treatment of jock itch
• there is no improvement within 4 weeks when used for athlete's foot or ringworm

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

• Clean the affected area and dry thoroughly
• Apply a thin layer 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• For 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 the scalp or nails

Other Information

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

Questions

1-888-DYNAREX

Label

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE CREAM USP, 2% 
miconazole nitrate cream usp, 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0340
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 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0340-1	425 g in 1 JAR; Type 0: Not a Combination Product	07/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/30/2018

Labeler - Cardinal Health (097537435)

Registrant - Dynarex Corporation (008124539)