Antifungal Powder

Antifungal Powder
SPL v4
SPL
SPL Set ID 60954089-5220-4f4c-8595-b5ee4562562c
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Silicon Dioxide Starch, Corn Dipotassium Glycyrrhizate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Active Ingredient                      Miconazol Nitrate 2%                         

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Active Ingredient                      Miconazol Nitrate 2%                         

Uses

• Proven clinically effective in the treatment of most: • athlete's foot • jock itch • ringworm • Relieves itching, scaling, cracking, burning, redness, soreness, irrita-tion, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.

Warnings

For external use only.

Questions

Call 1-833-605-84-74 9am-5 pm EST M-F

Directions

■ clean affected area and dry thoroughly

■ apply thin layer of powder to affected area twice daily (morning and night) or as direct-ed by a doctor

■ supervise children in the use of this product

■ for athlete's foot pay special attention to space 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 persists longer, consult a doctor

•this product is not effective on the scalp or nail

Do Not Use

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

Active Ingredient

Active Ingredient                     

Miconazol Nitrate 2%                         

Other Information

Store at room temperature

Inactive Ingredients

Colloidal silicon dioxide, Corn Starch, Dipotassium Glycyrhizinate, Sodium Benzoate

Principal Display Panel

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor If

■ irritation occurs

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

Keep Out of Reach of Children

Keep Out Of Reach Of Children

Do not let the powder get into your eyes. This product contains talc. Do not breathe in the powder as this may cause irritation of the airways. This is especially important for children and infants. If swallowed, contact a poison control center immediately.


Structured Label Content

Uses

• Proven clinically effective in the treatment of most: • athlete's foot • jock itch • ringworm • Relieves itching, scaling, cracking, burning, redness, soreness, irrita-tion, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.

Purpose

Antifungal

Warnings

For external use only.

Questions

Call 1-833-605-84-74 9am-5 pm EST M-F

Directions

■ clean affected area and dry thoroughly

■ apply thin layer of powder to affected area twice daily (morning and night) or as direct-ed by a doctor

■ supervise children in the use of this product

■ for athlete's foot pay special attention to space 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 persists longer, consult a doctor

•this product is not effective on the scalp or nail

Do Not Use

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

Active Ingredient

Active Ingredient                     

Miconazol Nitrate 2%                         

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, Corn Starch, Dipotassium Glycyrhizinate, Sodium Benzoate

Principal Display Panel (Principal Display panel)

When Using This Product (When using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ irritation occurs

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

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children

Do not let the powder get into your eyes. This product contains talc. Do not breathe in the powder as this may cause irritation of the airways. This is especially important for children and infants. If swallowed, contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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