SPL v2
SPL
SPL Set ID 483450d2-e38b-56ec-e063-6394a90acb5b
Route
TOPICAL
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2.5 mg) Salicylic Acid (5 mg)
Inactive Ingredients
Aqua Niacinamide Hydroxyacetophenone Durvillaea Antarctica Cetearyl Glucoside Ceramide 3 Ceramide 4 Piroctone Olamine Potassium Azeloyl Diglycinate Ceramide 5 Ceramide 6 Ii Pelargonium Graveolens Flowering Top Beta-sitosterol Shea Butter Cetearyl Alcohol Sitogluside Carbomer Homopolymer Type C Acetomonostearin Quaternium-73 O-cymen-5-ol N-carboxymethylchitosan Portulaca Oleracea Whole Xylitol Tremella Fuciformis Whole 1,2-hexanediol Ceramide 1 Glycerin Ammonium Acryloyldimethyltaurate/vp Copolymer Aloe Vera Leaf Methylpropanediol Chrysanthellum Indicum Whole Sophora Flavescens Root Azelaic Acid Anhydroxylitol Centella Asiatica Leaf Ceramide 2 Mentha Arvensis Leaf Chlorella Vulgaris Peg-100 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19
Description

Salicylic Acid 0.5% and Zinc Pyrithione 0.25%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

A gentle antifungal face cream designed for daily care of sensitive skin prone to seborrheic dermatitis and psoriasis.

Dosage and Administration

1. Apply a small amount to clean, dry facial skin, focusing on affected areas (forehead, brows, sides of nose). 2. Use twice daily or as directed by a healthcare professional. 3. Suitable for use under makeup.4. For external use only.

Description

Salicylic Acid 0.5% and Zinc Pyrithione 0.25%

Section 44425-7

Store in a cool, dry environment.

Section 50565-1

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9

Irritation occurs or if there is no improvement within 4 weeks.

Section 50570-1

Do not use it on children under 3 years of age.

Section 51727-6

AUQA,

GLYCERIN,

METHYLPROPANEDIOL,

PHYTOSTEROLS,

BUTYROSPERMUM PARKII (SHEA BUTTER),

NIACINAMIDE,

PHYTOSTERYL GLUCOSIDE,

CETEARYL GLUCOSIDE,

PEG-100 STEARATE,

GLYCERYL STEARATE/ACETATE,

CETEARYL ALCOHOL,

POTASSIUM AZELOYL DIGLYCINATE,

AZELAIC ACID,

MENTHA ARVENSIS LEAF EXTRACT,

CHRYSANTHELLUM INDICUM EXTRACT,

PORTULACA OLERACEA EXTRACT,

SOPHORA ANGUSTIFOLIA ROOT EXTRACT,

ALOE BARBADENSIS LEAF EXTRACT,

PELARGONIUM GRAVEOLENS FLOWER/LEAF/STEM EXTRACT,

CERAMIDE 1,

CERAMIDE 2,

CERAMIDE 3,

CERAMIDE 4,

CERAMIDE 5,

CERAMIDE 6 II,

PIROCTONE OLAMINE,

SALICYLIC ACID,

XYLITOL,

ANHYDROXYLITOL,

CENTELLA ASIATICA LEAF EXTRACT,

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT,

CHLORELLA VULGARIS EXTRACT,

DURVILLEA ANTARTICA EXTRACT,

CARBOXYMETHYL CHITOSAN,

CARBOMER,

AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,

HYDROXYACETOPHENONE,

1,2-HEXANEDIOL,

QUATERNIUM-73,

o-CYMEN-5-OL,

Section 51945-4

Section 53413-1

Email at: [email protected]

Section 55105-1

Keratolytic and Antifungal

Section 55106-9

Salicylic Acid 0.5% and Zinc Pyrithione 0.25%

Section 60561-8

Avoid contact with the eyes.

Structured Label Content

Indications and Usage (34067-9)

A gentle antifungal face cream designed for daily care of sensitive skin prone to seborrheic dermatitis and psoriasis.

Dosage and Administration (34068-7)

1. Apply a small amount to clean, dry facial skin, focusing on affected areas (forehead, brows, sides of nose). 2. Use twice daily or as directed by a healthcare professional. 3. Suitable for use under makeup.4. For external use only.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Store in a cool, dry environment.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Irritation occurs or if there is no improvement within 4 weeks.

Section 50570-1 (50570-1)

Do not use it on children under 3 years of age.

Section 51727-6 (51727-6)

AUQA,

GLYCERIN,

METHYLPROPANEDIOL,

PHYTOSTEROLS,

BUTYROSPERMUM PARKII (SHEA BUTTER),

NIACINAMIDE,

PHYTOSTERYL GLUCOSIDE,

CETEARYL GLUCOSIDE,

PEG-100 STEARATE,

GLYCERYL STEARATE/ACETATE,

CETEARYL ALCOHOL,

POTASSIUM AZELOYL DIGLYCINATE,

AZELAIC ACID,

MENTHA ARVENSIS LEAF EXTRACT,

CHRYSANTHELLUM INDICUM EXTRACT,

PORTULACA OLERACEA EXTRACT,

SOPHORA ANGUSTIFOLIA ROOT EXTRACT,

ALOE BARBADENSIS LEAF EXTRACT,

PELARGONIUM GRAVEOLENS FLOWER/LEAF/STEM EXTRACT,

CERAMIDE 1,

CERAMIDE 2,

CERAMIDE 3,

CERAMIDE 4,

CERAMIDE 5,

CERAMIDE 6 II,

PIROCTONE OLAMINE,

SALICYLIC ACID,

XYLITOL,

ANHYDROXYLITOL,

CENTELLA ASIATICA LEAF EXTRACT,

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT,

CHLORELLA VULGARIS EXTRACT,

DURVILLEA ANTARTICA EXTRACT,

CARBOXYMETHYL CHITOSAN,

CARBOMER,

AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,

HYDROXYACETOPHENONE,

1,2-HEXANEDIOL,

QUATERNIUM-73,

o-CYMEN-5-OL,

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email at: [email protected]

Section 55105-1 (55105-1)

Keratolytic and Antifungal

Section 55106-9 (55106-9)

Salicylic Acid 0.5% and Zinc Pyrithione 0.25%

Section 60561-8 (60561-8)

Avoid contact with the eyes.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.610305 · Updated: 2026-03-14T23:13:42.453292