DERMGENTLE SEBORRHEIC FACE CREAM- pyrithione zinc cream

Dermgentle Seborrheic Face Cream by

Drug Labeling and Warnings

Dermgentle Seborrheic Face Cream by is a Otc medication manufactured, distributed, or labeled by Dermgentle LLC, PRIME ENTERPRISES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications and usage

For the relief of the symptoms of seborrheic dermatitis such as skin flaking, redness, irritation and itching.

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%).

INGREDIENTS AND APPEARANCE

DERMGENTLE SEBORRHEIC FACE CREAM 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87261-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AQUA (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87261-100-01	57 g in 1 JAR; Type 0: Not a Combination Product	12/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/12/2025

Labeler - Dermgentle LLC (103217504)

Establishment
Name	Address	ID/FEI	Business Operations
PRIME ENTERPRISES, LLC		101946028	manufacture(87261-100) , label(87261-100) , analysis(87261-100) , pack(87261-100)