Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID fa54cf42-3ba7-b7b3-e053-6394a90aa7a0
Route
TOPICAL
Published
Effective Date 2023-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.8 g)
Inactive Ingredients
Honey Yellow Wax Hexylene Glycol Caprylyl Glycol Water Sunflower Oil Potassium Sorbate Ethylhexylglycerin Aloe Vera Leaf Phenoxyethanol Vitis Vinifera Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-27

Description

Active ingredient Salicylic Acid 1.8%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use For relief or controls the symptoms of Psoriasis

Dosage and Administration

Directions apply to affected areas one to four times daily or as directed by a doctor

Description

Active ingredient Salicylic Acid 1.8%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed,

Section 50567-7

When using this product do not get into eye. If contact occurs, rinse eyes thoroughly with water

Section 50570-1

Do not use if you have a very sensitive skin or sensitive to salicylic acid.

Section 51727-6

Inactive ingredients

Vitis vinefera (grape) seed oil, honey, aloe barbadensis leaf juice, beeswax, water (aqua), helianthus annuus (sunflower) seed oil, potassium sorbate, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, hexylene glycol

Section 51945-4

Section 55105-1

Purpose

Psoriasis Treatment

Section 55106-9

Active ingredient

Salicylic Acid 1.8%

Section 60561-8

Other information Store below 30°C (86°F).


Structured Label Content

Indications and Usage (34067-9)

Use For relief or controls the symptoms of Psoriasis

Dosage and Administration (34068-7)

Directions apply to affected areas one to four times daily or as directed by a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed,

Section 50567-7 (50567-7)

When using this product do not get into eye. If contact occurs, rinse eyes thoroughly with water

Section 50570-1 (50570-1)

Do not use if you have a very sensitive skin or sensitive to salicylic acid.

Section 51727-6 (51727-6)

Inactive ingredients

Vitis vinefera (grape) seed oil, honey, aloe barbadensis leaf juice, beeswax, water (aqua), helianthus annuus (sunflower) seed oil, potassium sorbate, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, hexylene glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Psoriasis Treatment

Section 55106-9 (55106-9)

Active ingredient

Salicylic Acid 1.8%

Section 60561-8 (60561-8)

Other information Store below 30°C (86°F).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)