Otc - Active Ingredient
Miconazole Nitrate
Folliculitis Treatment Cream
FDA Label NDC 85384-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Folliculitis Treatment Cream (NDC 85384-0004). 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 - keep out of reach of children, otc - stop use, 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
Helps soothe and care for skin affected by folliculitis.
Supports relieffrom itching, irritation, redness, scaling, and general skin discomfort.
Warnings
For external use only
Otc - Do Not Use
Do not use On children under 2 years of age unless directed by a doctor.
Otc - When Using
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.
Otc - Keep Out Of Reach Of Children
If swallowed,get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if Irritation occurs. There is no improvement within
4 weeks. Discomfort persists.
Other Safety Information
Store at 59-86°F (15-30°C). Close the cap tightly after use.
Otc - Questions
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 this produc
-lf the condition persists, consult a doctor.
Inactive Ingredient
Ingredients:Cnidium Monnieri Fruit, Gleditsia Sinensis Lam.
Typhonium Giganteum Whole, Stemona Japonica Root,
Smilax Glabra Roxb. Borneolum Syntheticum [chp],
Mentha Canadensis [who-dd], Equally extracted herbal extracts
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