Active Ingredient
Miconazole Nitrate 2%
Miconazole Nitrate Cream Usp, 2% Cream
FDA Label NDC 70000-0340
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 for the product Miconazole Nitrate Cream Usp, 2% (NDC 70000-0340). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
- Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet
Warnings
For external use only
Do Not Use
- on children under 2 years of age unless directed by a doctor
- for diaper rash
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 2 weeks when used for the treatment of jock itch
- there is no improvement within 4 weeks when used for athlete's foot or ringworm
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.
Directions
- Clean the affected area and dry thoroughly
- Apply a thin layer 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
- 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)
Inactive Ingredients
Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin
Questions
1-888-DYNAREX
* Please review the disclaimer below.
