SPL v3
SPL
SPL Set ID 1a9abb62-ae43-d5d6-e063-6294a90aa4a5
Route
TOPICAL
Published
Effective Date 2024-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Glycerin Succinic Acid Stevia Rebaudiuna Leaf Butylene Glycol Centella Asiatica Triterpenoids Cocoa Allantoin Houttuynia Cordata Flowering Top Alcohol 1,2-hexanediol Polyglyceryl-10 Laurate Madecassoside Dextrin, Corn Panthenol Propanediol Ammonium Polyacryloyldimethyl Taurate Niacinamide Asiatic Acid Tromethamine Salix Alba Bark Mentha X Rotundifolia Leaf Dipotassium Glycyrrhizate Madecassic Acid Water 2,3-butanediol Edetate Disodium Mentha Spicata Asiaticoside

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Use

For the treatment of acne.

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 .
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
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.
Package Label

Active Ingredient

Salicylic Acid 0.5%

Other Information

Store at room temperature

Inactive Ingredients

Water(Aqua/Eau), 2,3-Butanediol, Butylene Glycol, Alcohol Denat., 1,2-Hexanediol, Lactobacillus Ferment, Glycerin, Ammonium Polyacryloyldimeth yl Taurate, Niacinamide, Panthenol, Tromethamine, Dipotassium Glycyrrhizate, Allantoin, Succinic Acid, Polyglyceryl-10 Laurate, Propanediol, Stevia Rebaudiana Leaf/Stem Extract, Disodium EDTA, Dextrin, Theobroma Cacao (Cocoa) Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint) Extract, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Salix Alba (Willow) Bark Extract

Questions Or Comments?

Contact to www.dr-g.com

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

For the treatment of acne.

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 .
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
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.
Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Salicylic Acid 0.5%

Other Information

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Water(Aqua/Eau), 2,3-Butanediol, Butylene Glycol, Alcohol Denat., 1,2-Hexanediol, Lactobacillus Ferment, Glycerin, Ammonium Polyacryloyldimeth yl Taurate, Niacinamide, Panthenol, Tromethamine, Dipotassium Glycyrrhizate, Allantoin, Succinic Acid, Polyglyceryl-10 Laurate, Propanediol, Stevia Rebaudiana Leaf/Stem Extract, Disodium EDTA, Dextrin, Theobroma Cacao (Cocoa) Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint) Extract, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Salix Alba (Willow) Bark Extract

Questions Or Comments? (Questions or comments?)

Contact to www.dr-g.com

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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