MICONAZOLE NITRATE CREAM 2%- miconazole nitrate cream

Miconazole Nitrate Cream 2% by

Drug Labeling and Warnings

Miconazole Nitrate Cream 2% by is a Otc medication manufactured, distributed, or labeled by Ezricare Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum

Questions or comments?

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

Cures Most Athlete's Foot

Compared to the active ingredient in Micatin®*

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin®

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE CREAM 2% 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79503-106
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79503-106-30	1 in 1 CARTON	08/19/2021	07/01/2025
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/19/2021	07/01/2025

Labeler - Ezricare Llc (117573818)