Miconazole Nitrate 2% Cream Antifungal Cream
FDA Label NDC 70000-0718
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110 Dba Leader for the product Miconazole Nitrate 2% Cream Antifungal (NDC 70000-0718). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, otc - keep out of reach of children, uses, directions, warnings, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO, are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
All Leader Brand Products have a 100% money back guarantee.
Return to place of purchase of not satisfied.
* Please review the disclaimer below.
