Indications And Usage
For the relief of the symptoms of seborrheic dermatitis such as skin flaking, redness, irritation and itching.
Dermgentle Seborrheic Face Cream
FDA Label NDC 87261-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermgentle Llc for the product Dermgentle Seborrheic Face Cream (NDC 87261-100). 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 indications and usage, dosage and administration, warnings, inactive ingredients, purpose, keep out of reach of children, principal display panel and drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Adults and children 12 years of age and older:
• cleanse the skin gently and pat dry
• apply a thin layer of Seborrheic Face Cream to affected areas of the face and other seborrheic areas (such as eyebrows, sides of nose, and hairline)
• apply to affected areas one to four times daily or as directed by a doctor
Children under 12 years of age: ask a doctor.
Warnings
For external use only.
When using this product
• avoid contact with eyes. If product gets into eyes, rinse eyes thoroughly with water.
Ask a doctor before use if
• condition covers a large area of the body.
Do not use
• on skin that is broken or inflamed
• if you are allergic to ingredients in this product.
Stop use and ask a doctor if
• rash appears
• condition worsens or does not improve after regular use of this product as directed.
If pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredients
Aqua (water, eau), caprylic/capric triglyceride, glycerin, squalane, xylitol, cetyl alcohol, cetearyl alcohol, sodium stearoyl lactylate, phenoxyethanol.
Purpose
Seborrheic dermatitis treatment.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel And Drug Facts
Principal display panel and Drug Facts labeling for Dermgentle Seborrheic Face Cream (Pyrithione zinc 0.1%).
Front Panel Principal Display (Front Panel)
Drug Facts (Drug Facts)
* Please review the disclaimer below.
