Update-85498-011-01

Miconazole Nitrate 2%

Antifungal

For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
Relieves itching, burning, cracking, scaling, and discomfort caused by fungal infections.

For external use only

before use if you have

a condition that covers a large area of the body
sensitive skin or any known allergies to the ingredients

on children under 2 years of age except under the advice and supervision of a doctor.

avoid contact with eyes.

and ask a doctor if

irritation occurs.
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).

ask a health professional before use

If swallowed, get medical help or contact a Poison Control Center right away.

wash 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 and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
if conditions persist longer, ask a doctor.
this product is not effective on the scalp or nails.

Store at 20ºC to 25ºC (68ºF to 77ºF).
Close the cap tightly after use.

Sophora Flavescens Root, Glycerin, Propylene Glycol, Peppermint Oil, Sodium Acrylate, Sodium Acryloyldimethyl Taurate, Isohexadecane, Polysorbate-80, Dimethicone, Triethanolamine

product image

AOSORW ANTIFUNGAL CREAM
miconazole nitrate 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:85498-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOHEXADECANE (UNII: 918X1OUF1E)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:85498-011-01	120 g in 1 JAR; Type 0: Not a Combination Product	04/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	04/30/2025

Labeler - SpineStatus LLC (126780339)