SPL v1
SPL
SPL Set ID 468a7ca8-43c5-610f-e063-6294a90a07ac
Route
TOPICAL
Published
Effective Date 2025-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mg) Selenium Sulfide (1 mg)
Inactive Ingredients
Aqua Cocamidopropyl Betaine Sodium Chloride Ethylhexylglycerin Macadamia Ternifolia Seed Oil Hexamidine Diisethionate Phenoxyethanol Citric Acid Sodium Lauroyl Glutamate Cetearyl Alcohol Cocamidopropylamine Oxide Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-12-15 Until 2026-12-23

Description

Salicylic Acid 2% Selenium sulfide 1%


Medication Information

Warnings and Precautions

Warnings For external use only. Avoid contact with eyes. if contact occurs, rinse thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

Helps reduce dandruff and control flaking Helps soothe scalp itching and irritation Helps restore scalp comfort and balance ·Leaves hair feeling fresh, clean, and healthy

Dosage and Administration

Apply a small amount to wet hair and scalp. Gently massage into lather, leave on for 2-3 minutes. Rinse thoroughly. • Use 2-3 times per week or as needed.

Description

Salicylic Acid 2% Selenium sulfide 1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

1. Do not apply on other parts of the body, For topical use only on the scalp

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

Section 50570-1

You have no family history of hair loss,hair loss is sudden and/or patchy

You do not know the reason for you hair loss.

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease.

Section 51727-6

Water (Aqua), Sodium Lauroyl Glutamate, Cocamidopropyl Betaine, Cetearyl Alcohol, Cocamidopropylamine Oxide, Sodium Chloride, PPG-3 Caprylyl Ether, Polyquaternium-10, Polyquaternium-47, Disodium EDTA, Citric Acid, Propylene Glycol, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Hexamidine Diisethionate, Phenoxyethanol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Macadamia Ternifolia Seed Oil, Hydrolyzed Corn Starch, Coptis Chinensis Root Extract, Houttuynia Cordata Extract, Panax Ginseng Root Extract, Nymphaea Alba Flower Extract

Section 51945-4

Section 55105-1

Antibacterial shampoo

Section 55106-9

Salicylic Acid 2%

Selenium sulfide 1%


Structured Label Content

Indications and Usage (34067-9)

Helps reduce dandruff and control flaking Helps soothe scalp itching and irritation Helps restore scalp comfort and balance ·Leaves hair feeling fresh, clean, and healthy

Dosage and Administration (34068-7)

Apply a small amount to wet hair and scalp. Gently massage into lather, leave on for 2-3 minutes. Rinse thoroughly. • Use 2-3 times per week or as needed.

Warnings and Precautions (34071-1)

Warnings For external use only. Avoid contact with eyes. if contact occurs, rinse thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

1. Do not apply on other parts of the body, For topical use only on the scalp

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

Section 50570-1 (50570-1)

You have no family history of hair loss,hair loss is sudden and/or patchy

You do not know the reason for you hair loss.

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease.

Section 51727-6 (51727-6)

Water (Aqua), Sodium Lauroyl Glutamate, Cocamidopropyl Betaine, Cetearyl Alcohol, Cocamidopropylamine Oxide, Sodium Chloride, PPG-3 Caprylyl Ether, Polyquaternium-10, Polyquaternium-47, Disodium EDTA, Citric Acid, Propylene Glycol, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Hexamidine Diisethionate, Phenoxyethanol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Macadamia Ternifolia Seed Oil, Hydrolyzed Corn Starch, Coptis Chinensis Root Extract, Houttuynia Cordata Extract, Panax Ginseng Root Extract, Nymphaea Alba Flower Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial shampoo

Section 55106-9 (55106-9)

Salicylic Acid 2%

Selenium sulfide 1%


Advanced Ingredient Data


Raw Label Data

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