Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 3346f5f8-5793-47f6-8e71-250d3cc05c0d
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 mg)
Inactive Ingredients
Water Niacinamide Propylene Glycol Aluminum Starch Octenylsuccinate Peg-100 Stearate Cetyl Alcohol Sodium Hydroxide Capryloyl Salicylic Acid Xanthan Gum Stearyl Alcohol Myristyl Alcohol Octadecenedioic Acid Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-11-01 Until 2016-11-01

Description

Salicylic acid 1.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.5%

Uses
  • for the treatment of acne
  • 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 1.5%

Inactive Ingredients

water, aloe barbadensis leaf juice, di-C12-13 alkyl malate, niacinamide, cyclohexasiloxane, propylene glycol, aluminum starch octenylsuccinate, PEG-100 stearate, glyceryl stearate, cetyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, capryloyl salicylic acid, xanthan gum, zinc PCA, zingiber officinale (ginger) root extract, stearyl alcohol, myristyl alcohol, citric acid, potassium sorbate, octadecenedioic acid, sodium benzoate, citral, BHT

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
  • 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 1.5%

Inactive Ingredients (Inactive ingredients)

water, aloe barbadensis leaf juice, di-C12-13 alkyl malate, niacinamide, cyclohexasiloxane, propylene glycol, aluminum starch octenylsuccinate, PEG-100 stearate, glyceryl stearate, cetyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, capryloyl salicylic acid, xanthan gum, zinc PCA, zingiber officinale (ginger) root extract, stearyl alcohol, myristyl alcohol, citric acid, potassium sorbate, octadecenedioic acid, sodium benzoate, citral, BHT

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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