SPL v2
SPL
SPL Set ID 1f92122d-4873-8c1a-e063-6294a90a1c3b
Route
TOPICAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Polysorbate 20 Panthenol Glycerin Sucrose Hydroxyethyl Cellulose, Unspecified Citrulline Urea Water Tetrasodium Glutamate Diacetate Lactic Acid Propanediol Witch Hazel Alcohol Limonene, (-)- Succinic Acid Melaleuca Alternifolia (tea Tree) Leaf Oil Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-07

Description

Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the treatment of acne

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 every other day.
  • Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort

occurs, follow the directions stated above.

Description

Salicylic Acid 2%

Section 50565-1

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

Section 50567-7

When Using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.

■ If irritation occurs, only use one topical acne medication at a time.

Section 51727-6

Water/Aqua/Eau, SD Alcohol 40-B, Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Citrulline, Sucrose, Hydroxyethylcellulose, Urea, Alcohol, Polysorbate 20, Panthenol, Sodium Hydroxide, Succinic Acid, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tetrasodium Glutamate Diacetate, Limonene

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne

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 every other day.
  • Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort

occurs, follow the directions stated above.

Warnings and Precautions (34071-1)

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 50567-7 (50567-7)

When Using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.

■ If irritation occurs, only use one topical acne medication at a time.

Section 51727-6 (51727-6)

Water/Aqua/Eau, SD Alcohol 40-B, Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Citrulline, Sucrose, Hydroxyethylcellulose, Urea, Alcohol, Polysorbate 20, Panthenol, Sodium Hydroxide, Succinic Acid, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tetrasodium Glutamate Diacetate, Limonene

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)