61761914-3bb5-4034-a014-82500949672c

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

Purpose

Psoriasis Dandruff Seborrheic Dermatitis

Description

Salicylic Acid 3%


Medication Information

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.

Uses

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis
Purpose

Psoriasis Dandruff

Seborrheic Dermatitis

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

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

Description

Salicylic Acid 3%

Section 50565-1

Product Label

Active Ingredient

Salicylic Acid 3%


Structured Label Content

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.

Uses

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis
Purpose

Psoriasis Dandruff

Seborrheic Dermatitis

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

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

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Salicylic Acid 3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)