SPL v1
SPL
SPL Set ID 02a71ce4-baf5-4231-afd6-21ef0b22e931
Route
TOPICAL
Published
Effective Date 2025-11-05
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 Tea Tree Oil .alpha.-tocopherol Acetate Biotin Hydrolyzed Sheep Wool Keratin (200 Mw) Rosemary Oil Peppermint Oil Green Tea Leaf Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-30
Description

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Purpose

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Medication Information

Purpose

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Description

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Uses

Controls flaking, scaling, and itching associated with dandruff.

Section 50565-1

Warnings

For external use only



Do not use

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

When using this product

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

Stop use and ask a doctor if

  • Rash appears.
  • condition worsens 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. 
  • Repeat. 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

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

Purified Water, Sodium C-4-16 Olefin Sulfonate, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Trolamine, Phospholipid EFA, DL Panthenol USP Powder, Vitamin E Acetate, Biotin, Hydrolyzed Keratin, Oxidized Keratin, Rosemary Oil, Tea Tree Oil, Peppermint Oil,Green Tea Extract, Ascorbic Acid, Manuka Honey

Active Ingredient                                            Purpose

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Structured Label Content

Uses

Controls flaking, scaling, and itching associated with dandruff.

Section 50565-1 (50565-1)

Warnings

For external use only



Do not use

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

When using this product

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

Stop use and ask a doctor if

  • Rash appears.
  • condition worsens 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. 
  • Repeat. 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)

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)

Purified Water, Sodium C-4-16 Olefin Sulfonate, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Trolamine, Phospholipid EFA, DL Panthenol USP Powder, Vitamin E Acetate, Biotin, Hydrolyzed Keratin, Oxidized Keratin, Rosemary Oil, Tea Tree Oil, Peppermint Oil,Green Tea Extract, Ascorbic Acid, Manuka Honey

Active Ingredient                                            Purpose (Active ingredient                                            Purpose)

Salicylic Acid 3%                                        Psoriasis and Dandruff Seborrheic Dermatitis

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:56.700058 · Updated: 2026-03-14T23:13:27.116919