Active Ingredient
Miconazole Nitrate 2% USP
1236-cs Antifungal Powder (talc Free) Powder
FDA Label NDC 67777-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product 1236-cs Antifungal Powder (talc Free) (NDC 67777-313). 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, use(s), warnings, do not use, ask a doctor or pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use(S)
• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), and ringworm (tinea corporis)
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching or burning feet.
Warnings
For External Use Only
Do Not Use
• On children under 2 years of age unless directed by a doctor
• For diaper rash
Ask A Doctor Or Pharmacist
Before use if you are taking anticoagulants such as warfarin
When Using This Product
• Avoid contact with the eyes
Stop Use And Ask A Doctor If
• Irritation occurs
• There is no improvement within 2 weeks when used for the treatment of jock itch
• There is no improvement within 4 weeks when used for athlete's foot or ringworm
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Clean the affected area and dry thoroughly. Apply a thin layer over the 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 spaces 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 nails
Other Information
• Store at Controlled Room Temperature • Do not use if "Remove before Use" seal is missing
Inactive Ingredients
Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate
Questions?
1-888-396-2739 Monday - Friday 9AM - 5PM EST
Label
1236-CS Antifungal Powder (Talc Free)
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