Active Ingredient
Miconazole Nitrate 2%
Cardae Folliculitis Cream
FDA Label NDC 87786-033
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Cardae Folliculitis Cream (NDC 87786-033). 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, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• Treats most folliculitis, tinea capitis, lichen, and psoriasis.
• Relieves the itching, irritation, redness, scaling and discomfort accompanying these conditions.
Warnings
For external use only.
Do Not Use
It on children under 2 years of age unless directed by a doctor.
When Using
Avoid contact with eyes.
If contact occurs, rinse the eyes thoroughly with water.
Stop Use
If irritation occurs or there is no improvement within 4 weeks,discontinue use and consult a doctor.
Ask Doctor
If irritation occurs or there is no improvement within 4 weeks,discontinue use and consult a doctor.
Keep Out Of Reach Of Children
Keep out of the reach of Children.
Directions
• 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 when using this product.
• If the condition persists longer, consult a doctor.
Other Information
• Store at 59-85 °F(15-30 °C)
• Close the cap tightly after use
Inactive Ingredients
Water, Dimethicone, Mineral Oil, Petrolatum, Glycerin, Glyceryl Monostearate, 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
Principal Display Panel
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