FDA Label for Miconazole Nitrate
View Indications, Usage & Precautions
Miconazole Nitrate Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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
- proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, scaling, cracking, burning and discomfort associated with those conditions
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 Use And Ask A Doctor If
- irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
- irritation occurs or if there is no improvement within 2 weeks (for jock itch)
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 the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- use daily for 4 weeks. If condition persists longer, consult a doctor.
- pay special attention to the spaces between the toes
- wear well-fitting, ventilated shoes
- change shoes and socks at least once daily
For athlete's foot:
For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
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 15° - 30°C (59° - 86°F)
- lot number and expiration date: see crimp of tube or see box
- to open: unscrew cap, use pointed end on cap to puncture seal
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
Other
Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811
Rev. 10/09 R2
8280719 7805
Repackaged by
Rebel Distributors Corp.
Thousand Oaks, CA 91320
* Please review the disclaimer below.