Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f9daadf9-a9d3-4f2d-af07-5f0b70f7803f
Route
TOPICAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Niacinamide Lactic Acid Sodium Hydroxide Aloe Vera Leaf Chlorphenesin Hyaluronate Sodium Hamamelis Virginiana Top Azelaic Acid Trisodium Ethylenediamine Disuccinate Citric Acid Monohydrate Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-30

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent new acne blemishes from forming

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 2%

Inactive Ingredients

water, glycerin, niacinamide, lactic acid, sodium hydroxide, aloe barbadensis leaf juice, chlorphenesin, sodium hyaluronate, hamamelis virginiana (witch hazel) bark/leaf/twig extract, aloe barbadensis leaf extract, azelaic acid, trisodium ethylenediamine disuccinate, citric acid, potassium sorbate, sodium benzoate

Questions Or Comments?

1-888-842-9371 1-888-THAYER-1

M-F 9am-5:30 pm ET

When Using This Product

skin irritation and dryness is 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

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

• clears acne blemishes and allows skin to heal

• helps prevent new acne blemishes from forming

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 2%

Inactive Ingredients (Inactive ingredients)

water, glycerin, niacinamide, lactic acid, sodium hydroxide, aloe barbadensis leaf juice, chlorphenesin, sodium hyaluronate, hamamelis virginiana (witch hazel) bark/leaf/twig extract, aloe barbadensis leaf extract, azelaic acid, trisodium ethylenediamine disuccinate, citric acid, potassium sorbate, sodium benzoate

Questions Or Comments? (Questions or comments?)

1-888-842-9371 1-888-THAYER-1

M-F 9am-5:30 pm ET

When Using This Product (When using this product)

skin irritation and dryness is 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

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

All Sections (JSON)