Other
Drug Facts
Miconazole Nitrate Cream
FDA Label NDC 68599-1471
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Miconazole Nitrate (NDC 68599-1471). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Miconazole Nitrate 2%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
Treats most jock itch, ringworm and athlete’s foot
Warnings
Warnings
Do not use
- on children under 2 years of age
- for diaper rash.
For external use only.
Avoid contact with eyes.
Otc - Stop Use
Consult a Doctor
If irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,
or within 2 weeks for jock itch.
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.
Dosage & Administration
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
- Supervise children in the use of this product.
- Pay special attention to the spaces between toes
- wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- use daily for 4 weeks
- use daily for 2 weeks.
Athlete’s foot
Athlete’s foot and ringworm
Jock Itch
If condition persists longer, consult a doctor.
Other Safety Information
Other Information
- This product is not effective on scalp or nails.
- Store at 59-86°F (15-30°C).
Inactive Ingredient
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,
DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,
Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).
Package Label.Principal Display Panel
NDC 68599-1471-4
McKesson
Antifungal Cream 2%
MICONAZOLE
NITRATE
Relieves itching, cracking, scaling and
discomfort associated with most jock itch,
ringworm and athlete’s foot.
4 fl oz
(118.3 mL)
MFR # 53-6391
* Please review the disclaimer below.
