SPL v2
SPL
SPL Set ID a0ede9a8-ff34-4c00-a6ca-f227d0df17a7
Route
TOPICAL
Published
Effective Date 2021-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Glycerin Butylene Glycol Propanediol Peg-30 Castor Oil Glycyrrhizinate Dipotassium Phenoxyethanol Glycolic Acid Betasizofiran Xanthan Gum Sodium Hydroxide Farnesol Ethylhexylglycerin Sulfur

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-07-01

Description

Salicylic Acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 2%

Uses

Clears acne blemishes and allows the skin to heal

Warnings

For External Use Only

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 ingested, seek medical help or contact Poison

Control Center immediately

Directions
  • Clean the skin thoroughly before applying this product
  • cover the entire affected area/spot 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
Drug Facts

Product Label

Other Information

Store below 30°C (86° F)

Active Ingredient 

Salicylic Acid 2%

Inactive Ingredients

water, alcohol denat, glycerin, butylene glycol, propanediol, PEG-30 castor oil, dipotassium glycyrrhizate, phenoxyethanol, glycolic acid, sclerotium gum,xanthum gum, sodium hydroxide, farnesol, ethylhexylglycerin, sulfur


Structured Label Content

Uses

Clears acne blemishes and allows the skin to heal

Purpose

Acne treatment

Warnings

For External Use Only

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 ingested, seek medical help or contact Poison

Control Center immediately

Directions
  • Clean the skin thoroughly before applying this product
  • cover the entire affected area/spot 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
Drug Facts

Product Label (Product label)

Other Information (Other information)

Store below 30°C (86° F)

Active Ingredient  (Active ingredient )

Salicylic Acid 2%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat, glycerin, butylene glycol, propanediol, PEG-30 castor oil, dipotassium glycyrrhizate, phenoxyethanol, glycolic acid, sclerotium gum,xanthum gum, sodium hydroxide, farnesol, ethylhexylglycerin, sulfur


Advanced Ingredient Data


Raw Label Data

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