MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by

Drug Labeling and Warnings

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110 dba LEADER, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Anti-Fungal

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
• relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Directions

Directions: Clean the affected area and dry thoroughly

• Apply a thin layer of the product over the affected area twice daily, morning and night or as directed by a doctor.
• Supervise children in the use of this product

For Athletes Foot

• Use daily for 4 weeks. If condition persists, consult a doctor
• Pay special Attention to the spaces between the toes
• Wear well fitting, ventilated shoes
• Change socks at least once daily

For Ringworm

• Use daily for 4 weeks. If condition persists, consult a doctor

For Jock Itch

• Use Daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp and nails

​

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not useon children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes.

Stop use and ask a doctor irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)

If irritation occurs or if there is no improvement within 2 weeks (for Jock Itch).

INACTIVE INGREDIENT

Inactive ingredients: Alcohol, Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, Mineral Oil, Mono and di glycerides, Petrolatum, Polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine.

Other Information

Store at 15° - 30° c (59° - 86° f) Lot number and expiration date see crimp of tube or see box. To open: Unscrew cap, tear safety seal off.

SPL UNCLASSIFIED SECTION

Distributed by:
Cardinal Health TM
Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care ™ since 1979

©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO, are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

All Leader Brand Products have a 100% money back guarantee.

Return to place of purchase of not satisfied.

Packaging

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0718
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
SODIUM LAURETH-4 PHOSPHATE (UNII: 4N589ZVP40)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
ETHYLPARABEN (UNII: 14255EXE39)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0718-1	1 in 1 BOX	05/12/2025
1		28 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	05/12/2025

Labeler - Cardinal Health 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)