SPL v1
SPL
SPL Set ID 3d27b19e-2c64-9822-e063-6394a90a4971
Route
TOPICAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (1 mg)
Inactive Ingredients
Sodium Benzoate Piroctone Olamine Water Glycerin Sodium Lauryl Sulfate Portulaca Oleracea Whole Sophora Flavescens Whole Centella Asiatica Camellia Sinensis Leaf Glycol Distearate Fragrance Fresh Citrus Floral Orc1501495 Sodium Chloride Prinsepia Utilis Seed Cocamidopropyl Betaine Dimethiconol (14000 Cst) Sodium Methyl Cocoyl Taurate Guar Hydroxypropyltrimonium Chloride Zinc Pca Lauric Acid Avena Sativa (oat) Kernel Oil Sodium Laureth Sulfate Citric Acid Sulfur Glycol Stearate Ethylhexylglycerin Zingiber Officinale (ginger) Root Oil Ceramide Np Rhinacanthus Nasutus Whole Diaminopyrimidine Oxide Sodium Salicylate Limosilactobacillus Fermentum Phenoxyethanol Laureth-3 Platycladus Orientalis Leaf Macadamia Integrifolia Seed Oil Rosmarinus Officinalis (rosemary) Leaf Oil Hydrogenated Castor Oil Dichlorobenzyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-25

Description

WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE DIMETHICONOL SODIUM CHLORIDE DIAMINOPYRIMIDINE OXIDE SODIUM LAURYL SULFATE SODIUM SALICYLATE GLYCERIN PHENOXYETHANOL GLYCOL DISTEARATE SODIUM BENZOATE FRAGRANCE FRESH CITRUS FLORAL ORC1501495 SODIUM METHYL COCOYL TAURATE HYDROGENATED CASTOR OIL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE ZINC PCA CITRIC ACID LAURETH-3 DICHLOROBENZYL ALCOHOL SULFUR GLYCOL STEARATE LAURIC ACID ETHYLHEXYLGLYCERIN PLATYCLADUS ORIENTALIS LEAF AVENA SATIVA (OAT) KERNEL OIL CENTELLA ASIATICA LIMOSILACTOBACILLUS FERMENTUM CAMELLIA SINENSIS LEAF PORTULACA OLERACEA WHOLE SOPHORA FLAVESCENS WHOLE MACADAMIA INTEGRIFOLIA SEED OIL ZINGIBER OFFICINALE (GINGER) ROOT OIL ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL PRINSEPIA UTILIS SEED CERAMIDE NP RHINACANTHUS NASUTUS WHOLE


Medication Information

Warnings and Precautions

For external use onlyWhen using this product avoid contact with the eyes. lf contact occurs, rinseeyes thoroughly with water, Stop use and ask a doctor if condition worsens ordoes not improve after regular use of this product as directed. Keep outof reach of children.lf swallowed, get medical help or contact a PoisonControl Centerright away.

Indications and Usage

Fights and helps prevent recurrence ofscalp flaking and itching associated with dandruff.

Dosage and Administration

For best results, use at least twice a week or as directed bya doctor. wet hair and apply small amount of shampoo and massageonto scalp. rinse and repeat if desired.

Description

WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE DIMETHICONOL SODIUM CHLORIDE DIAMINOPYRIMIDINE OXIDE SODIUM LAURYL SULFATE SODIUM SALICYLATE GLYCERIN PHENOXYETHANOL GLYCOL DISTEARATE SODIUM BENZOATE FRAGRANCE FRESH CITRUS FLORAL ORC1501495 SODIUM METHYL COCOYL TAURATE HYDROGENATED CASTOR OIL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE ZINC PCA CITRIC ACID LAURETH-3 DICHLOROBENZYL ALCOHOL SULFUR GLYCOL STEARATE LAURIC ACID ETHYLHEXYLGLYCERIN PLATYCLADUS ORIENTALIS LEAF AVENA SATIVA (OAT) KERNEL OIL CENTELLA ASIATICA LIMOSILACTOBACILLUS FERMENTUM CAMELLIA SINENSIS LEAF PORTULACA OLERACEA WHOLE SOPHORA FLAVESCENS WHOLE MACADAMIA INTEGRIFOLIA SEED OIL ZINGIBER OFFICINALE (GINGER) ROOT OIL ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL PRINSEPIA UTILIS SEED CERAMIDE NP RHINACANTHUS NASUTUS WHOLE

Section 50565-1

Keep outof reach of children.lf swallowed, get medical help or contact a PoisonControl Center right away.

Section 51727-6

WATER

SODIUM LAURETH SULFATE

COCAMIDOPROPYL BETAINE

DIMETHICONOL

SODIUM CHLORIDE

DIAMINOPYRIMIDINE OXIDE

SODIUM LAURYL SULFATE

SODIUM SALICYLATE

GLYCERIN

PHENOXYETHANOL

GLYCOL DISTEARATE

SODIUM BENZOATE

FRAGRANCE FRESH CITRUS FLORAL ORC1501495

SODIUM METHYL COCOYL TAURATE

HYDROGENATED CASTOR OIL

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

ZINC PCA

CITRIC ACID

LAURETH-3

DICHLOROBENZYL ALCOHOL

SULFUR

GLYCOL STEARATE

LAURIC ACID

ETHYLHEXYLGLYCERIN

PLATYCLADUS ORIENTALIS LEAF

AVENA SATIVA (OAT) KERNEL OIL

CENTELLA ASIATICA

LIMOSILACTOBACILLUS FERMENTUM

CAMELLIA SINENSIS LEAF

PORTULACA OLERACEA WHOLE

SOPHORA FLAVESCENS WHOLE

MACADAMIA INTEGRIFOLIA SEED OIL

ZINGIBER OFFICINALE (GINGER) ROOT OIL

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

PRINSEPIA UTILIS SEED

CERAMIDE NP

RHINACANTHUS NASUTUS WHOLE

Section 51945-4

Section 55105-1

Helps prevent recurrence ofscalp flaking and itchingassociated with dandruff.

Section 55106-9

Selenium Sulfide 1%

Piroctone Olamine 0.2%


Structured Label Content

Indications and Usage (34067-9)

Fights and helps prevent recurrence ofscalp flaking and itching associated with dandruff.

Dosage and Administration (34068-7)

For best results, use at least twice a week or as directed bya doctor. wet hair and apply small amount of shampoo and massageonto scalp. rinse and repeat if desired.

Warnings and Precautions (34071-1)

For external use onlyWhen using this product avoid contact with the eyes. lf contact occurs, rinseeyes thoroughly with water, Stop use and ask a doctor if condition worsens ordoes not improve after regular use of this product as directed. Keep outof reach of children.lf swallowed, get medical help or contact a PoisonControl Centerright away.

Section 50565-1 (50565-1)

Keep outof reach of children.lf swallowed, get medical help or contact a PoisonControl Center right away.

Section 51727-6 (51727-6)

WATER

SODIUM LAURETH SULFATE

COCAMIDOPROPYL BETAINE

DIMETHICONOL

SODIUM CHLORIDE

DIAMINOPYRIMIDINE OXIDE

SODIUM LAURYL SULFATE

SODIUM SALICYLATE

GLYCERIN

PHENOXYETHANOL

GLYCOL DISTEARATE

SODIUM BENZOATE

FRAGRANCE FRESH CITRUS FLORAL ORC1501495

SODIUM METHYL COCOYL TAURATE

HYDROGENATED CASTOR OIL

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

ZINC PCA

CITRIC ACID

LAURETH-3

DICHLOROBENZYL ALCOHOL

SULFUR

GLYCOL STEARATE

LAURIC ACID

ETHYLHEXYLGLYCERIN

PLATYCLADUS ORIENTALIS LEAF

AVENA SATIVA (OAT) KERNEL OIL

CENTELLA ASIATICA

LIMOSILACTOBACILLUS FERMENTUM

CAMELLIA SINENSIS LEAF

PORTULACA OLERACEA WHOLE

SOPHORA FLAVESCENS WHOLE

MACADAMIA INTEGRIFOLIA SEED OIL

ZINGIBER OFFICINALE (GINGER) ROOT OIL

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

PRINSEPIA UTILIS SEED

CERAMIDE NP

RHINACANTHUS NASUTUS WHOLE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent recurrence ofscalp flaking and itchingassociated with dandruff.

Section 55106-9 (55106-9)

Selenium Sulfide 1%

Piroctone Olamine 0.2%


Advanced Ingredient Data


Raw Label Data

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