Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 5726d12c-708c-46e6-a584-9e5c7a544fc8
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 mg)
Inactive Ingredients
Alcohol Water Methylpropanediol Glycolic Acid Diisopropyl Adipate Octadecenedioic Acid Hydroxyethylpiperazine Ethane Sulfonic Acid Citric Acid Monohydrate Capryloyl Salicylic Acid Sodium Hydroxide Polyquaternium-69 (350000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2005-08-01 Until 2005-08-01

Description

Salicylic acid 1.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.5%

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

Section 51945-4

Warnings

For external use only

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

Active Ingredient



Salicylic acid 1.5%

Other Information

store in a cool, dark place

Inactive Ingredients

alcohol denat., water, methylpropanediol, glycolic acid, diisopropyl adipate, octadecenedioic acid, hydroxethylpiperazine ethane sulfonic acid, citric acid, capryloyl salicylic acid, sodium hydroxide, polyquaternium-10

Questions Or Comments?

1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product

skin irritation and dryness is more liekly 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.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

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

Active Ingredient (Active ingredient)



Salicylic acid 1.5%

Other Information (Other information)

store in a cool, dark place

Inactive Ingredients (Inactive ingredients)

alcohol denat., water, methylpropanediol, glycolic acid, diisopropyl adipate, octadecenedioic acid, hydroxethylpiperazine ethane sulfonic acid, citric acid, capryloyl salicylic acid, sodium hydroxide, polyquaternium-10

Questions Or Comments? (Questions or comments?)

1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product (When using this product)

skin irritation and dryness is more liekly 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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