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

Active Ingredient

Active ingredient

Salicylic Acid 1.8%

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 60561-8

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Salicylic Acid 1.8%

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

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 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)