Otc - Active Ingredient
MICONAZOLE NITRATE 2%
Recuren Plus Jock Itch Cream
FDA Label NDC 87014-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Regeneren Plus Ltd for the product Recuren Plus Jock Itch Cream (NDC 87014-004). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, other safety information, otc - stop use, 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
Otc - Purpose
Antifungal
Indications & Usage
For the effective treatment of jock itch (tinea cruris), athlete’s foot (tinea pedis), ringworm (tinea corporis), and other common fungal skin infections.
Warnings
For external use only
Otc - Do Not Use
On children under 3 years of age
Other Safety Information
Store in a cool, dry place
Otc - Stop Use
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help immediately.
Otc - When Using
Avoid contact with the eyes
Otc - Ask Doctor
You have concerns about skin irritation or if symptoms persist beyond 4 weeks.
Dosage & Administration
1. Apply a small amount of cream to the affected area 2–3 times daily. 2. Make sure the skin is clean and dry before application. 3. For first-time users, perform a patch test on a small area of skin to check for sensitivity.
Inactive Ingredient
Aqua (Water), Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.
Otc - Questions
Please contact the email: [email protected]
* Please review the disclaimer below.
