FDA Label for Miconazole Nitrate 2% Cream Antifungal
View Indications, Usage & Precautions
Miconazole Nitrate 2% Cream Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110 Dba Leader. 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 2%
Purpose
Anti-Fungal
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Uses
- proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
- relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Directions
Directions: Clean the affected area and dry thoroughly
- Apply a thin layer of the product over the 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, consult a doctor
- Pay special Attention to the spaces between the toes
- Wear well fitting, ventilated shoes
- Change socks at least once daily
- Use daily for 4 weeks. If condition persists, consult a doctor
- Use Daily for 2 weeks. If condition persists longer, consult a doctor.
For Athletes Foot
For Ringworm
For Jock Itch
This product is not effective on scalp and nails
Warnings
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
Do not useon 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 • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
If irritation occurs or if there is no improvement within 2 weeks (for Jock Itch).
Inactive Ingredient
Inactive ingredients: Alcohol, Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, Mineral Oil, Mono and di glycerides, Petrolatum, Polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine.
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, tear safety seal off.
Other
Distributed by:
Cardinal Health
TM
Dublin, Ohio 43017
www.myleader.com
1-800-200-6313
Essential to Care ™ since 1979
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