FDA Label for Antifungal Powder

View Indications, Usage & Precautions

Antifungal Powder Product Label

The following document was submitted to the FDA by the labeler of this product Aldermed Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.