SPL v2
SPL
SPL Set ID 1a9a7753-af2a-4be6-e063-6394a90a8cc5
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
Cetearyl Alcohol Sodium Phytate Mentha Spicata Asiaticoside Pentaerythrityl Tetraethylhexanoate Arachidyl Alcohol Sodium Polyacryloyldimethyl Taurate Xanthan Gum Centella Asiatica Triterpenoids Polysorbate 60 Asiatic Acid Propanediol Madecassic Acid Cetearyl Olivate Tromethamine Glyceryl Stearate Mentha X Rotundifolia Leaf Cetyl Alcohol Butylene Glycol 1,2-hexanediol Houttuynia Cordata Flowering Top Tocopherol Caprylic/capric Triglyceride Behenyl Alcohol Arachidyl Glucoside Carbomer Betaine Ethylhexylglycerin Madecassoside Glycerin Water Ceramide Np Succinic Acid Phytosphingosine Pentylene Glycol Sorbitan Olivate

Identifiers & Packaging

Pill Appearance
Color: white
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), Glycerin, Caprylic/Capric Triglyceride, Propanediol, Pentaerythrityl Tetraethylhexanoate, Vinyl Dimethicone, 1,2-Hexanediol, Cetearyl Olivate, Cetearyl Alcohol, Cetyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Glyceryl Stearate, Sorbitan Olivate, Tromethamine, Behenyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Arachidyl Glucoside, Carbomer, Lactobacillus Ferment, Butylene Glycol, Betaine, Ceramide NP, Succinic Acid, Xanthan Gum, Phytosphingosine, Ethylhexylglycerin, Sodium Phytate, Polysorbate 60, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint) Extract, Centella Asiatica Extract, Tocopherol, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside

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), Glycerin, Caprylic/Capric Triglyceride, Propanediol, Pentaerythrityl Tetraethylhexanoate, Vinyl Dimethicone, 1,2-Hexanediol, Cetearyl Olivate, Cetearyl Alcohol, Cetyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Glyceryl Stearate, Sorbitan Olivate, Tromethamine, Behenyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Arachidyl Glucoside, Carbomer, Lactobacillus Ferment, Butylene Glycol, Betaine, Ceramide NP, Succinic Acid, Xanthan Gum, Phytosphingosine, Ethylhexylglycerin, Sodium Phytate, Polysorbate 60, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint) Extract, Centella Asiatica Extract, Tocopherol, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside

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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