Miconazole Nitrate

Manufacturer: A-S Medication Solutions
Effective date: 2025-02-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:55:55

Label at a glance#

ProductMiconazole Nitrate

Active ingredientMICONAZOLE NITRATE

Label structure12 sections

Indications and uses

effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Dosage and administration

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 jo...

Storage and handling

To open: unscrew cap, use pointed end on cap to puncture seal store at 20° - 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon children less than 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this productavoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
condition persists
there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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
not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

To open: unscrew cap, use pointed end on cap to puncture seal
store at 20° - 25°C (68° - 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1071

NDC: 50090-1071-0 15 g in a TUBE / 1 in a CARTON