Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 04df2f5d-77f0-4553-9d8c-3f10628736ae
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Isononyl Isononanoate Butylene Glycol Kaolin Zinc Sulfate Sarcosine Hyaluronate Sodium Sodium Hydroxide Trisodium Ethylenediamine Disuccinate Ascorbyl Glucoside Acetic Acid Biosaccharide Gum-1 Caprylyl Glycol Lactic Acid Maltodextrin Pentylene Glycol Sodium Polyacrylate (2500000 Mw) Xanthan Gum Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

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
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%

Flammable Until Dry.

Keep away from flames and heat.

Inactive Ingredients

water, glycerin, butylene glycol, isononyl isononanoate, kaolin, hydrolyzed algin, zinc sulfate, bifida ferment lysate, sarcosine, sodium hyaluronate, sodium hydroxide, trisodium ethylenediamine disuccinate, ascorbyl glucoside, acetic acid, acrylates/c10-30 alkyl acrylate crosspolymer, biosaccharide gum-1, caprylyl glycol, lactic acid, maltodextrin, pentylene glycol, sodium polyacrylate, xanthan gum, sodium benzoate, fragrance

Questions Or Comments?

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

When Using This Product

kin 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
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%

Flammable Until Dry. (Flammable until dry.)

Keep away from flames and heat.

Inactive Ingredients (Inactive ingredients)

water, glycerin, butylene glycol, isononyl isononanoate, kaolin, hydrolyzed algin, zinc sulfate, bifida ferment lysate, sarcosine, sodium hyaluronate, sodium hydroxide, trisodium ethylenediamine disuccinate, ascorbyl glucoside, acetic acid, acrylates/c10-30 alkyl acrylate crosspolymer, biosaccharide gum-1, caprylyl glycol, lactic acid, maltodextrin, pentylene glycol, sodium polyacrylate, xanthan gum, sodium benzoate, fragrance

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

When Using This Product (When using this product)

kin 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

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