Otc - Active Ingredient
Miconazole Nitrate 2%
Folliculitis Treatment Cream
FDA Label NDC 87278-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Folliculitis Treatment Cream (NDC 87278-013). 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, 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
FOLLICULITISINEA CAPITISLICHENPSORIASIS
Warnings
FOR EXTERNAL USE ONLY.
Otc - Do Not Use
D0 NOT USE it on children under 2 years of age unless directed by a doctor.
Otc - When Using
WHEN USING THIS PRODUCT, avoid contact with the eyes, if contact occurs, rinse the eyes very thoroughly with water.
Otc - Stop Use
STOP USING AND ASK A PHYSICIAN if irritation occurs or there is no improvement within 4 weeks.
STOP USE AND ASK A DOCTOR if discomfort persists.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF YOUNG CHILDREN
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.
Inactive Ingredient
Water
Gentiana
Sophora Flavescens
Rhinacanthus Nasutus
Stemona Tuberosa Lour
Herba Violae
Euphorbia Hirta
Murraya Exotica
Peppermint
Glycerin
Methylparaben
Propylene Glycol
Silicone Oil
Triethanolamine
Package Label.Principal Display Panel
Label1 (Label)
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