Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e700b28f-268a-4384-a9bb-a83c42b41313
Route
TOPICAL
Published
Effective Date 2012-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2.8 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Bidens Tripartita Flowering Top Calcium Stearate Cod Liver Oil Eucalyptus Oil Honey Lavender Oil Lysozyme Hydrochloride Matricaria Recutita Mineral Oil Petrolatum Retinol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-01
Description

Active Ingredient Salicylic Acid 2%

Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • Ask a doctor before use if condition covers a large part of the body
  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if condition worsens or does not improve after regular use as directed



Indications and Usage

Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitis

Dosage and Administration

Directions

Apply to affected area one to four times daily or as directed by a doctor

Description

Active Ingredient Salicylic Acid 2%

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Alpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.

Section 51945-4





Section 55105-1

Purpose:

psoriasis and seborrheic dermatitis

Section 55106-9

Active Ingredient

Salicylic Acid 2%

Structured Label Content

Indications and Usage (34067-9)

Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitis

Dosage and Administration (34068-7)

Directions

Apply to affected area one to four times daily or as directed by a doctor

Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • Ask a doctor before use if condition covers a large part of the body
  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if condition worsens or does not improve after regular use as directed



Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Alpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.

Section 51945-4 (51945-4)





Section 55105-1 (55105-1)

Purpose:

psoriasis and seborrheic dermatitis

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.209503 · Updated: 2026-03-14T22:53:20.556394