Otc - Active Ingredient
Miconazole Nitrate 1.5%
Folliculitis Cream
FDA Label NDC 85398-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Folliculitis Cream (NDC 85398-001). 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, otc - when using, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-fungal
Indications & Usage
- Treats most folliculitis, tinea capitis, lichen, and psoriasis.
- Relieves the itching, irritation, redness, scaling and discomfort accompanying thee conditions.
Warnings
For external use only
Otc - Do Not Use
it on children under 2 years of age unless directed by a doctor.
Otc - When Using
avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.
keep out of the reach of Children.
Otc - Stop Use
If irritation occurs or there is no improvement within 4 weeks.
Dosage & Administration
- Wash the affected area and dry thoroughly.
- Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor.
- Supervise children in the use of the product.
- If the condition persists longer, consult a doctor.
Other Safety Information
- Store at 59-85 °F(15-30 °C)
- Close the cap tightly after use
Inactive Ingredient
Water, Dimethicone, Mineral Oil, Petrolatum, Glycerin, Glyceryl Monostearate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Rhinacanthus nasutus Leaf, Viola philippica Whole, Euphorbia hirta Whole, Murraya paniculata Whole, Mentha haplocalyx Oil, Borneol, Sophora flavescens Root, Cnidium monnieri Fruit, Bassia scoparia Whole, Dictamnus dasycarpus Root Bark, Smilax glabra Tuber, Dianthus superbus Flowering Top, Chlorhexidine Acetate
Otc - Questions
contact us at [email protected]
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
