MICONAZOLE NITRATE 2% ANTIFUNGAL GEL- miconazole nitrate gel

Miconazole Nitrate 2% Antifungal Gel by

Drug Labeling and Warnings

Miconazole Nitrate 2% Antifungal Gel by is a Otc medication manufactured, distributed, or labeled by Puretek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Anti-Fungal

Uses

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort

Warnings

For external use only. Not for opthalmic use.

Do not use

on children under 2 years of age unless directed by Doctor.

When using this product

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 right away.

Directions

● Wash the affected area and dry thoroughly.

● Apply a thin layer of the product 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 20° to 25°C (68° to 77°F) [see USP Controlled RoomTemperature]. Avoid excessive heat. Do not use if package is damaged.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Caprylyl Glycol, Dimethicone, Dimethyl Sulfoxide, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% ANTIFUNGAL GEL 
miconazole nitrate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-207
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
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PEG-4 (UNII: R95B8J264J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
AQUA (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-207-07	85 g in 1 TUBE; Type 0: Not a Combination Product	11/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	11/07/2025

Labeler - Puretek Corporation (785961046)