Antifungal Powder
FDA Label NDC 87236-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Antifungal Powder (NDC 87236-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active Ingredient                     

Miconazol Nitrate 2%                         

Purpose

Antifungal

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.

Do Not Use

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

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)

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

Other Information

Store at room temperature

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.

Inactive Ingredients

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

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