FDA Label for Antifungal
View Indications, Usage & Precautions
Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Llc. 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
Miconazole Nitrate 2%
Purpose
Antifungal
Uses
- for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for the treatment of most superficial skin infections caused by yeast (candida albicans)
- relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings
For external use only.
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with the eyes.
Stop and ask a doctor if
- for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
- for jock itch - if irritation occurs, or if there is no improvement within 2 weeks
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of powder 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 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 conditions persist longer, consult a doctor
- this product is not effective on the scalp or nails
Other Information
- Store between 20° to 25°C (68° to 77°F)
- Protect from freezing. Avoid excessive heat.
- Do not use if package is damaged.
Inactive Ingredients
allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.
Questions?
call toll free 1-800-630-8895
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