ANTIFUNGAL- miconazole nitrate cream

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate USP 2%

Purpose

Antifungal

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruis), and ringworm (tinea corporis)

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

Warnings

For External Use Only

Do not use

On children under 2 years of age unless directed by a doctor

Avoid contact with eyes

Stop use and ask a doctor if

Irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor for athlete's foot and ringworm.

Irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor for jock itch.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 controlled room temperature 20°-25°C (68°-77°F)

Tamper evident. Do not use if seal is damaged.

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, zinc oxide

Questions?

1-888-Dynarex Monday-Friday, 9am-5pm EST

Label 1230-MN

Label 1233-MN

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-710
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ZINC OXIDE (UNII: SOI2LOH54Z)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHLOROCRESOL (UNII: 36W53O7109)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-710-02	2 in 1 CASE	03/24/2026
1	NDC: 67777-710-01	144 in 1 BOX
1		5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-710-05	4 in 1 CASE	03/24/2026
2	NDC: 67777-710-04	6 in 1 BOX
2	NDC: 67777-710-03	113 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	03/24/2026

Labeler - Dynarex Corporation (008124539)