Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a2369870-cf81-4ebd-a354-858212d67d0e
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 mg)
Inactive Ingredients
Water Alcohol Hydroxyethylpiperazine Ethane Sulfonic Acid Glycolic Acid Glycerin Propanediol Sodium Hydroxide Sodium Polyacrylate (2500000 Mw) Adenosine Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Ascorbyl Glucoside Vitreoscilla Lysate Trisodium Ethylenediamine Disuccinate Xanthan Gum Panthenol Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-12 Until 2023-06-01

Description

Salicylic acid 1%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1%

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
  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because too much 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%

Flammable Until Dry.

Keep away from flames and heat.

Inactive Ingredients

water, alcohol denat., hydroxyethylpiperazine ethane sulfonic acid, glycolic acid, glycerin, propanediol, sodium hydroxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, sodium polyacrylate, adenosine, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, vitreoscilla ferment, trisodium ethylenediamine disuccinate, xanthan gum, panthenol, menthol

Questions Or Comments?

Call toll free 1-877-37-VICHY (84249)

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

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
Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because too much 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%

Flammable Until Dry. (Flammable until dry.)

Keep away from flames and heat.

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., hydroxyethylpiperazine ethane sulfonic acid, glycolic acid, glycerin, propanediol, sodium hydroxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, sodium polyacrylate, adenosine, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, vitreoscilla ferment, trisodium ethylenediamine disuccinate, xanthan gum, panthenol, menthol

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-37-VICHY (84249)

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

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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