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 Aru Pharma 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.
Drug Facts
Active Ingredient
Miconazole Nitrate USP 2%
Purpose
Antifungal
Uses
- effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.
Warnings
For external use only
Do not use on children less than 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 • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
- 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
- not effective on the scalp or nails
Inactive Ingredients
Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water
Other Information
• Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30°C (86°F). Do not freeze. • see carton or tube crimp for lot number and expiration date
Questions Or Comments?
1 844 500-2729 between 9 am and 4 pm EST, Monday to Friday.
Other
CURES MOST ATHLETE'S FOOT
Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining
Compared to the active ingredient in Micatin
Distributed by.
ARU PHARMA INC.
MOUNT VERNON, NY 10552
www.qpackrx.com
Packaging
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