Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 14429a1d-7db9-49a7-85d6-22374d03ecaa
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (12 mg)
Inactive Ingredients
Water Glycerin Butylene Glycol Niacinamide Dimethicone Cetostearyl Alcohol Isohexadecane Sodium Hydroxide Ammonium Polyacryloyldimethyl Taurate Laureth-4 Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Propylene Glycol Glycyrrhizinate Dipotassium Hydroxyethyl Cellulose, Unspecified Dimethiconol (40 Cst) Trisodium Ethylenediamine Disuccinate Zinc Pidolate Glyceryl Monostearate Peg-100 Stearate Maltodextrin Menthol Limosilactobacillus Fermentum Sage Chamomile

Identifiers & Packaging

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

Description

Salicylic acid 1.2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.2%

Uses
  • for the treatment of acne
  • clears acne blemishes and allows skin to heal
  • helps keep skin clear of 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 1.2%

Inactive Ingredients

water, glycerin, butylene glycol, niacinamide, dimethicone, cetearyl alcohol, isohexadecane, sodium hydroxide, ammonium polyacryloyldimethyl taurate, laureth-4, polyacrylate crosspolymer-6, propylene glycol, dipotassium glycyrrhizate, hydroxyethylcellulose, dimethiconol, trisodium ethylenediamine disuccinate, zinc PCA, glyceryl stearate, PEG-100 stearate, silica silylate, hydroxypropyl starch phosphate, maltodextrin, menthol, lactobacillus ferment, salvia officinalis (sage) leaf extract, chamomilla recutita (matricaria) flower extract

Questions Or Comments?

Call toll free 1-800-946-4453

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 keep skin clear of 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 1.2%

Inactive Ingredients (Inactive ingredients)

water, glycerin, butylene glycol, niacinamide, dimethicone, cetearyl alcohol, isohexadecane, sodium hydroxide, ammonium polyacryloyldimethyl taurate, laureth-4, polyacrylate crosspolymer-6, propylene glycol, dipotassium glycyrrhizate, hydroxyethylcellulose, dimethiconol, trisodium ethylenediamine disuccinate, zinc PCA, glyceryl stearate, PEG-100 stearate, silica silylate, hydroxypropyl starch phosphate, maltodextrin, menthol, lactobacillus ferment, salvia officinalis (sage) leaf extract, chamomilla recutita (matricaria) flower extract

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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

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