MICONAZOLE CREAM- miconazole nitrate cream

Miconazole Cream by

Drug Labeling and Warnings

Miconazole Cream by is a Otc medication manufactured, distributed, or labeled by Aldermed Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate USP 2.0%

Purpose

Antifungal

Uses

• for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• relieves itching, scaling, cracking, burning, discomfort and chafing associated with jock itching, burning feet irritation,

Warnings

For external use only

Do not use

• on children under 2 years of age unless directed by doctor

When using this product

• avoid contact with the eyes

Stop use and ask a doctor

■ irritation oc:curs

■ 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 and ringworm

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

■ clean 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

■ to open: unscrew cap, pull tab to remove foil seal

■ store at 20° to 25°C (68° to 77°F)

■preserve in tight container

■ see tube crimp for lot number and expiration 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, zinc oxide.

Questions?

Call 1-833-605-8474 9am-5pm EST M-F

Package Label

INGREDIENTS AND APPEARANCE

MICONAZOLE CREAM 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87236-013
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
CHLOROCRESOL (UNII: 36W53O7109)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
ZINC OXIDE (UNII: SOI2LOH54Z)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETEARETH-12 (UNII: 7V4MR24V5P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87236-013-04	113 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/01/2026

Labeler - Aldermed Inc. (144887712)