Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b5ea8f33-8f18-7464-e053-2a95a90a39b2
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-07

Description

Active Ingredients: Salicylic Acid 1.8%


Medication Information

Warnings and Precautions

Warning: For external use only.

Indications and Usage

Uses:

  • For relief or controls the symptoms of Psoriasis.
Dosage and Administration

Directions:

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or evert other day.
Description

Active Ingredients: Salicylic Acid 1.8%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor: If irritation becomes severe.

Section 50567-7

When using this product - avoid contact with eyes. If contactc occurs, rinse eyes thoroughly with lukewarm 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 Vinifera (Grape) Seed Oil, Honey, Aloe Barbadensis Leaf juice, Beeswax, Water (Aqua), Potassium Sorbate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

Section 51945-4

Manufactured For

Psoriasis Honey CO LLC.

Hayward, CA, 94545

Section 55105-1

Purpose: Psoriasis Treatment

Section 55106-9

Active Ingredients:

Salicylic Acid 1.8%

Section 60561-8

Other Information: Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • For relief or controls the symptoms of Psoriasis.
Dosage and Administration (34068-7)

Directions:

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or evert other day.
Warnings and Precautions (34071-1)

Warning: For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor: If irritation becomes severe.

Section 50567-7 (50567-7)

When using this product - avoid contact with eyes. If contactc occurs, rinse eyes thoroughly with lukewarm 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 Vinifera (Grape) Seed Oil, Honey, Aloe Barbadensis Leaf juice, Beeswax, Water (Aqua), Potassium Sorbate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

Section 51945-4 (51945-4)

Manufactured For

Psoriasis Honey CO LLC.

Hayward, CA, 94545

Section 55105-1 (55105-1)

Purpose: Psoriasis Treatment

Section 55106-9 (55106-9)

Active Ingredients:

Salicylic Acid 1.8%

Section 60561-8 (60561-8)

Other Information: Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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