SPL v1
SPL
SPL Set ID 61761914-3bb5-4034-a014-82500949672c
Route
TOPICAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Trolamine Panthenol .alpha.-tocopherol Acetate Tea Tree Oil Green Tea Leaf Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-28

Description

Salicylic Acid 3%

Purpose

Psoriasis Dandruff Seborrheic Dermatitis


Medication Information

Purpose

Psoriasis Dandruff

Seborrheic Dermatitis

Description

Salicylic Acid 3%

Uses

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis
Section 50565-1

Warnings

For external use only

Do not use

  • On damaged or inflamed scalp
  • If you are allergic to ingredients in this product

When using this product

  • Avoid contact with eyes
  • If contact occurs, rinse the eyes thoroughly with water.

Stop use and ask a doctor if:

  • Rash appears
  • Condition worsen or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
 Adults and children aged 12 and over
  •  wet hair thoroughly
  • Apply shampoo, generously lather, then rinse thoroughly. Repeate
  • Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control 
dandruff
 Children under 12 years old.                   Ask a doctor

Product Label

Active Ingredient

Salicylic Acid 3%

Other Information
  • Store between 20°-25° C (68° -77° F)
  • See bottom panel for lot number and expiration date.
Inactive Ingredients

Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract, Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea Tree Oil, Trolamine, Vitamin E Acetate


Structured Label Content

Uses

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis
Section 50565-1 (50565-1)

Purpose

Psoriasis Dandruff

Seborrheic Dermatitis

Warnings

For external use only

Do not use

  • On damaged or inflamed scalp
  • If you are allergic to ingredients in this product

When using this product

  • Avoid contact with eyes
  • If contact occurs, rinse the eyes thoroughly with water.

Stop use and ask a doctor if:

  • Rash appears
  • Condition worsen or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
 Adults and children aged 12 and over
  •  wet hair thoroughly
  • Apply shampoo, generously lather, then rinse thoroughly. Repeate
  • Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control 
dandruff
 Children under 12 years old.                   Ask a doctor

Product Label (Product label)

Active Ingredient

Salicylic Acid 3%

Other Information (Other information)
  • Store between 20°-25° C (68° -77° F)
  • See bottom panel for lot number and expiration date.
Inactive Ingredients (Inactive ingredients)

Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract, Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea Tree Oil, Trolamine, Vitamin E Acetate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)