Antifungal Cream

Antifungal Cream
SPL v2
SPL
SPL Set ID 8be4bbfa-424c-4ccf-b8bc-65b16c126053
Route
TOPICAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Mineral Oil Apricot Kernel Oil Peg-6 Esters Pegoxol 7 Stearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Miconazole nitrate, USP 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate, USP 2%

Use(s)

■ 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

For external use only

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 the spaces between the toes; wear well-filling, 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

Do Not Use

on children under 2 years of age unless directed by a doctor.

Other Information

■ 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°C to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s)

Miconazole nitrate, USP 2%

Inactive Ingredients

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

Questions Or Comments?

Call 1-833-285-4151

Principal Display Panel

Antifungal Cream

Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)



When Using This Product

avoid contact with the eyes.

Stop Use and Ask Doctor If

■ irritation occurs

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

Keep Out of Reach of Children

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


Structured Label Content

Use(s) (USE(S))

■ 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

Purpose (PURPOSE)

Antifungal

Warnings (WARNINGS)

For external use only

Directions (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 the spaces between the toes; wear well-filling, 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

Do Not Use (DO NOT USE)

on children under 2 years of age unless directed by a doctor.

Other Information (OTHER INFORMATION)

■ 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°C to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Miconazole nitrate, USP 2%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Antifungal Cream

Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)



When Using This Product (WHEN USING THIS PRODUCT)

avoid contact with the eyes.

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

■ irritation occurs

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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