Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2532352e-eabc-4565-9437-b8801db6937a
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Sodium Hydroxide Glycolic Acid Lactic Acid Niacinamide Ceramide Np Ceramide Ap Ceramide 1 Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Behentrimonium Methosulfate Triethyl Citrate Hyaluronate Sodium Sodium Lauroyl Lactylate Cholesterol Chlorphenesin Edetate Disodium Guaraprolose (1300 Mpa.s At 1%) Caprylyl Glycol Xanthan Gum Phytosphingosine Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-18

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses
  • 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%

Other Information

• store at 20 – 25ºC (68 – 77ºF)

• protect from excessive moisture

Inactive Ingredients

water, glycerin, sodium hydroxide, glycolic acid, lactic acid, niacinamide, ceramide NP, ceramide AP, ceramide EOP, carbomer, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, chlorphenesin, disodium EDTA, hydroxypropyl guar, caprylyl glycol, xanthan gum, phytosphingosine, benzoic acid

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
  • 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%

Other Information (Other information)

• store at 20 – 25ºC (68 – 77ºF)

• protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

water, glycerin, sodium hydroxide, glycolic acid, lactic acid, niacinamide, ceramide NP, ceramide AP, ceramide EOP, carbomer, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, chlorphenesin, disodium EDTA, hydroxypropyl guar, caprylyl glycol, xanthan gum, phytosphingosine, benzoic acid

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)