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 Taro Pharmaceuticals U.s.a., 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.
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Drug Facts
Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
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, burning and discomfort that can accompany these conditions.
Warnings
For external use only
Otc - Do Not Use
Do not use on children less than 2 years of age unless directed by a doctor
Otc - When Using
When using this product avoid contact with eyes
Stop Use And Ask A Doctor If
- irritation occurs
- condition persists
- 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
Other Information
- To open: unscrew cap, use pointed end on cap to puncture seal
- store at 20° - 25°C (68° - 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water
Questions?
Call 1-866-923-4914
Principal Display Panel - 15 G Tube Carton
Cures Most Athlete's Foot
Antifungal Cream
Miconazole Nitrate
Cream USP, 2%
Antifungal Cream
NET WT 1/2 oz (15 g)
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