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

Purpose

Antifungal

Description

Miconazole nitrate, USP 2%


Medication Information

Warnings

For external use only

Purpose

Antifungal

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

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.

Inactive Ingredients

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

Description

Miconazole nitrate, USP 2%

Principal Display Panel

Antifungal Cream

Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)



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

Do Not Use

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

Active Ingredient(s)

Miconazole nitrate, USP 2%

Questions Or Comments?

Call 1-833-285-4151

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

Warnings (WARNINGS)

For external use only

Purpose (PURPOSE)

Antifungal

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

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Antifungal Cream

Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)



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

Do Not Use (DO NOT USE)

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

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

Miconazole nitrate, USP 2%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

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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