Miconazole Nitrate 2% 1.3 g/131g
Jock Itch Spray · AEROSOL, SPRAY · Walgreens Company
Miconazole Nitrate 2% is an over-the-counter antifungal spray used to treat jock itch and other fungal skin infections. You apply it directly to the affected skin area as directed on the package.
Key Facts
- Brand Name
- Miconazole Nitrate 2%
- Generic Name
- Jock Itch Spray
- NDC Code (Product)
0363-5353- Manufacturer
- Walgreens Company
- Strength
- 1.3 g/131g
- Dosage Form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Marketing Status
- Application #
- M005
- Marketing Start
- 10/28/2021
Recall History
GSK Consumer Healthcare
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Cherry Hill Sales Co.
CGMP Deviations
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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 healthcare professional • Supervise children in the use of this product. For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily. For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional. For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional. This product is not effective on the scalp or nails.
Warnings
Warnings For external use only. Do not use if the safety-sealed tube is punctured or damaged. Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes. Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
Frequently Asked Questions
What is Miconazole Nitrate 2% used for?
Miconazole Nitrate 2% is an over-the-counter antifungal spray used to treat jock itch and other fungal skin infections. You apply it directly to the affected skin area as directed on the package.
Is Miconazole Nitrate 2% a controlled substance?
Miconazole Nitrate 2% is not classified as a controlled substance by the DEA.
What is the generic name for Miconazole Nitrate 2%?
The generic name for Miconazole Nitrate 2% is Jock Itch Spray. There are 5 other brand versions of Jock Itch Spray.
What is the NDC code for Miconazole Nitrate 2% 1.3 g/131g?
The NDC (National Drug Code) for Miconazole Nitrate 2% 1.3 g/131g is 0363-5353, listed by Walgreens Company.