83818-011

83818-011
SPL v1
SPL
SPL Set ID 33bebbe9-e0ab-2f7d-e063-6294a90add4e
Route
TOPICAL
Published
Effective Date 2025-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Polyquaternium-10 (1000 Mpa.s At 2%) Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin C12-15 Alkyl Benzoate Guar Hydroxypropyltrimonium Chloride Sodium Laureth Sulfate Sodium Benzoate Fragrance 13576 Cocamidopropyl Betaine 1,2-hexanediol C12-16 Alcohols Water Sophora Flavescens Root Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Dimethicone Polyquaternium-7 Sodium Chloride Glycerin Thymus Vulgaris Leaf Menthol Sodium Isostearoyl Lactylate Decyl Glucoside Cocamide Mea Cnidium Monnieri Fruit Cocamidopropyl Pg-dimonium Chloride Phosphate Curcuma Longa (turmeric) Root Laureth-23 Tea-dodecylbenzenesulfonate Sodium Lauryl Sulfate Edetate Disodium Sodium Sulfate Cetyl Alcohol Dimethiconol (40 Cst) C12-13 Alkyl Lactate Acacia Senegal Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-27

Description

Salicylic Acid 1%

Purpose

Anti-Dandruff, Anti-Psoriasis, Anti-Seborrheic Dermatitis


Medication Information

Purpose

Anti-Dandruff, Anti-Psoriasis, Anti-Seborrheic Dermatitis

Description

Salicylic Acid 1%

Use

Helps relieve itching, flaking, and scaling associated with dandruff infections.

Stop Use

If irritation occurs, stop using the product and consult a doctor.

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water immediately. If irritation occurs, stop using the product and consult a doctor. Keep out of reach of children. Do not use on broken or infected scalp. Consult doctor before use if pregnant or breastfeeding. This product is not recommended for individuals under 18 years old.

Questions

Please feel free to reach out to us at [email protected].

Ask Doctor

Consult doctor before use if pregnant or breastfeeding.

Directions

Thoroughly wet your hair and scalp. Apply shampoo and gently massage it into your scalp for 3-5 minutes. Rinse thoroughly with warm water. Repeat if necessary. For best results, use daily or at least three times a week.

Do Not Use

Do not use on broken or infected scalp. This product is not recommended for individuals under 18 years old.

When Using

Avoid contact with eyes. If contact occurs, rinse thoroughly with water immediately.

Active Ingredient

Salicylic Acid 1%

Other Information

• Store at room temperature.

• Avoid freezing and direct sunlight.

• Discard 12 months after opening.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Decyl Glucoside, Sodium Lauryl Sulfate, Dimethicone, Cocamide MEA, Cocamidopropyl Betaine, Cetyl Alcohol, Dimethiconol, Fragrance, C12-13 Alkyl Lactate, Acacia Senegal Gum, Salicylic Acid, Sophora Flavescens Root Extract, Sodium Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Isostearoyl Lactylate, Polyquaternium-10, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Menthol, Polyquaternium-7, Sodium Chloride, Cnidium Monnieri Fruit Extract, Curcuma Longa Root Extract, Disodium EDTA, Glycerin, Sodium Sulfate, Thymus Vulgaris Flower/Leaf Extract, TEA-Dodecylbenzenesulfonate, Laureth-23, Phenoxyethanol, 1,2-Hexanediol, Caprylyl Glycol, C12-16 Alcohols, Ethylhexylglycerin, C12-15 Alkyl Benzoate, Guar Hydroxypropyltrimonium Chloride.

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children.


Structured Label Content

Use

Helps relieve itching, flaking, and scaling associated with dandruff infections.

Purpose

Anti-Dandruff, Anti-Psoriasis, Anti-Seborrheic Dermatitis

Stop Use

If irritation occurs, stop using the product and consult a doctor.

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water immediately. If irritation occurs, stop using the product and consult a doctor. Keep out of reach of children. Do not use on broken or infected scalp. Consult doctor before use if pregnant or breastfeeding. This product is not recommended for individuals under 18 years old.

Questions

Please feel free to reach out to us at [email protected].

Ask Doctor

Consult doctor before use if pregnant or breastfeeding.

Directions

Thoroughly wet your hair and scalp. Apply shampoo and gently massage it into your scalp for 3-5 minutes. Rinse thoroughly with warm water. Repeat if necessary. For best results, use daily or at least three times a week.

Do Not Use (Do not use)

Do not use on broken or infected scalp. This product is not recommended for individuals under 18 years old.

When Using

Avoid contact with eyes. If contact occurs, rinse thoroughly with water immediately.

Active Ingredient

Salicylic Acid 1%

Other Information (Other information)

• Store at room temperature.

• Avoid freezing and direct sunlight.

• Discard 12 months after opening.

Inactive Ingredients (Inactive ingredients)

Water, Sodium Laureth Sulfate, Decyl Glucoside, Sodium Lauryl Sulfate, Dimethicone, Cocamide MEA, Cocamidopropyl Betaine, Cetyl Alcohol, Dimethiconol, Fragrance, C12-13 Alkyl Lactate, Acacia Senegal Gum, Salicylic Acid, Sophora Flavescens Root Extract, Sodium Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Isostearoyl Lactylate, Polyquaternium-10, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Menthol, Polyquaternium-7, Sodium Chloride, Cnidium Monnieri Fruit Extract, Curcuma Longa Root Extract, Disodium EDTA, Glycerin, Sodium Sulfate, Thymus Vulgaris Flower/Leaf Extract, TEA-Dodecylbenzenesulfonate, Laureth-23, Phenoxyethanol, 1,2-Hexanediol, Caprylyl Glycol, C12-16 Alcohols, Ethylhexylglycerin, C12-15 Alkyl Benzoate, Guar Hydroxypropyltrimonium Chloride.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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