SPL v3
SPL
SPL Set ID 2cf2a287-1ba8-2d71-e063-6394a90aee5a
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 mg)
Inactive Ingredients
Potassium Sorbate Glycerin Dextrin, Potato 1,2-hexanediol Ethylhexylglycerin Hydroxyacetophenone Thymus Serpyllum Turmeric Amylopectin, Unspecified Source Propanediol Caprylate Sodium C14-16 Olefin Sulfonate Ketoconazole Adiantum Capillus-veneris Leaf Water Sodium Benzoate Caprylyl Glycol Polydextrose Polysorbate 80 Cocamidopropyl Hydroxysultaine Luviset 360 Niacinamide Sodium Hydroxide Polyquaternium-7 Trisodium Ethylenediamine Disuccinate Hexylene Glycol Citric Acid Monohydrate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-11

Description

Salicylic Acid 1.8%

Purpose

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


Medication Information

Purpose

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

Description

Salicylic Acid 1.8%

Section 51945-4

Warnings

For external use only

Directions

Adults and children 12 years ad over
  • Wet hair thoroughly
  • Apply shampoo, masage into scalp, and rinse thoroughly. Repeat
  • For best results, use at least every other day for 8 weeks or as directed by a doctor. Then use as needed to control dandruff.
Children under 12 years
  • Ask a doctor

Do Not Use

o On scalp that is broken or inflamed

o If you are allergic to ingredients in this product

Active Ingredient

Salicylic Acid 1.8%

Other Information
  • Store at 20°C to 25°C (68°F-77°F)
  • See top panel for lot number and expiration date
Indications & Usage

Controls flaking, scaling and itching associated with dandruff.

Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl

Hydroxysultaine, Acrylates Copolymer, Glycerin, Propanediol

Caprylate, Polysorbate 80, Niacinamide, Ketoconazole, Curcuma

Longa (Turmeric) Root Extract, Adiantum Capillus-Veneris Leaf

Extract, Thymus Serpyllum Extract, Caprylyl Glycol, 1,2-Hexanediol,

Polyquaternium-7, Amylopectin, Dextrin, Polydextrose, Trisodium

Ethylenediamine Disuccinate, Citric Acid, Sodium Hydroxide,

Hexylene Glycol, Potassium Sorbate, Hydroxyacetophenone,

Ethylhexylglycerin, Sodium Benzoate, Phenoxyethanol

Questions Or Comments?

Call 1-866-544-3339

When Using This Product
  • Avoid contact with eyes
  • If product gets into eyes, rinse thoroughly with water
Pregnancy Or Breast Feeding
  • If pregnant or breast-feeding, ask a doctor before use
Stop Use and Ask A Doctor If
  • Rash appears
  • Condition worsens or does not improve in 2-4 weeks
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


Structured Label Content

Section 51945-4 (51945-4)

Purpose

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

Warnings

For external use only

Directions

Adults and children 12 years ad over
  • Wet hair thoroughly
  • Apply shampoo, masage into scalp, and rinse thoroughly. Repeat
  • For best results, use at least every other day for 8 weeks or as directed by a doctor. Then use as needed to control dandruff.
Children under 12 years
  • Ask a doctor

Do Not Use (Do not use)

o On scalp that is broken or inflamed

o If you are allergic to ingredients in this product

Active Ingredient

Salicylic Acid 1.8%

Other Information (Other information)
  • Store at 20°C to 25°C (68°F-77°F)
  • See top panel for lot number and expiration date
Indications & Usage

Controls flaking, scaling and itching associated with dandruff.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl

Hydroxysultaine, Acrylates Copolymer, Glycerin, Propanediol

Caprylate, Polysorbate 80, Niacinamide, Ketoconazole, Curcuma

Longa (Turmeric) Root Extract, Adiantum Capillus-Veneris Leaf

Extract, Thymus Serpyllum Extract, Caprylyl Glycol, 1,2-Hexanediol,

Polyquaternium-7, Amylopectin, Dextrin, Polydextrose, Trisodium

Ethylenediamine Disuccinate, Citric Acid, Sodium Hydroxide,

Hexylene Glycol, Potassium Sorbate, Hydroxyacetophenone,

Ethylhexylglycerin, Sodium Benzoate, Phenoxyethanol

Questions Or Comments? (Questions or comments?)

Call 1-866-544-3339

When Using This Product (When using this product)
  • Avoid contact with eyes
  • If product gets into eyes, rinse thoroughly with water
Pregnancy Or Breast Feeding (Pregnancy or breast feeding)
  • If pregnant or breast-feeding, ask a doctor before use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash appears
  • Condition worsens or does not improve in 2-4 weeks
Keep Out of Reach of Children (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


Advanced Ingredient Data


Raw Label Data

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