Miconazole Nitrate

Manufacturer: A-S Medication Solutions
Effective date: 2023-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:03:54

Label at a glance#

ProductMiconazole Nitrate

Active ingredientMICONAZOLE NITRATE

Label structure12 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm for effective relief of itching, scaling, cracking, burning, and discomfort

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 the 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; fo...

Storage and handling

do not use if foil seal on tube opening is broken or missing to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use store at room temperature 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

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

proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
for effective relief of itching, scaling, cracking, burning, and discomfort

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 (1-800-222-1222) right away.

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 the 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 lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

do not use if foil seal on tube opening is broken or missing
to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
store at room temperature 15°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5674

NDC: 50090-5674-0 28 g in a TUBE / 1 in a CARTON