Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 72977030-d9b6-435f-b321-edcbbb731587
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Water Butylene Glycol Cetostearyl Alcohol Dimethicone Sodium Polyacrylate (2500000 Mw) Glycerin Polyoxyl 20 Cetostearyl Ether Polysorbate 60 Hydrogenated Polydecene (550 Mw) Ethylhexyl Palmitate Aluminum Starch Octenylsuccinate Ppg-2 Myristyl Ether Propionate Phenoxyethanol .alpha.-glucan Oligosaccharide Squalane Medium-chain Triglycerides Caprylyl Glycol Zinc Gluconate C12-15 Alkyl Lactate Morus Alba Root Ethylhexylglycerin Hexylene Glycol Levomenol Safflower Oil Ppg-25-laureth-25 Sodium Hydroxide Kojic Acid Hydroxypropyl Betadex Sophora Flavescens Root Edetate Disodium Polyquaternium-11 (1000000 Mw) Arctostaphylos Uva-ursi Leaf Glycyrrhiza Glabra Scutellaria Baicalensis Root Hyaluronate Sodium Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01 Until 2025-05-02

Description

Salicylic Acid 0.5%


Medication Information

Description

Salicylic Acid 0.5%

Use

● For the management of acne.

Section 55105-1

Purpose

Acne Treatment

Warnings

For external use only.

When using this product • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if ● irritation becomes severe.

Directions

Sensitivity Test for New User:

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • 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 0.5%

Inactive Ingredients

Water, Butylene Glycol, Cetearyl Alcohol, Dimethicone, Sodium Polyacrylate, Glycerin, Ceteareth-20, Polysorbate 60, Hydrogenated Polydecene, Ethylhexyl Palmitate, Aluminum Starch Octenylsuccinate, PPG-2 Myristyl Ether Propionate, Phenoxyethanol, Alpha-Glucan Oligosaccharide, Squalane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Zinc Gluconate, C12-15 Alkyl Lactate, Morus Alba Root Extract, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Safflower Oil/Palm Oil Aminopropanediol Esters, PPG-5-Laureth-5, Sodium Hydroxide, Kojic Acid, Hydroxypropyl Cyclodextrin, Sophora Angustifolia Root Extract, Disodium EDTA, Polyquaternium-11, Arctostaphylos Uva-Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Allantoin

Questions Or Comments?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Fort Worth, TX 76177

All trademarks are the property of their respective owners

cetaphil.com

Keep Out of Reach of Children

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

Principle Display Panel 3 Fl Oz Carton

Cetaphil®



ACNE

GENTLE CLEAR

Mattifying

Acne

Moisturizer


0.5% Salicylic Acid Acne Treatment



Oil Absorbing moisturizer

provides a matte finish while

clearing breakouts



Salicylic Acid,

Prebiotic



Dermatologist Recommended

Sensitive Skin 



3 FL OZ (89 mL)

Distributed by: Galderma Laboratories, L.P., Dallas TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com

Made in Canada

P56653-3





           


Structured Label Content

Use

● For the management of acne.

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Warnings

For external use only.

When using this product • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if ● irritation becomes severe.

Directions

Sensitivity Test for New User:

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • 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 0.5%

Inactive Ingredients

Water, Butylene Glycol, Cetearyl Alcohol, Dimethicone, Sodium Polyacrylate, Glycerin, Ceteareth-20, Polysorbate 60, Hydrogenated Polydecene, Ethylhexyl Palmitate, Aluminum Starch Octenylsuccinate, PPG-2 Myristyl Ether Propionate, Phenoxyethanol, Alpha-Glucan Oligosaccharide, Squalane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Zinc Gluconate, C12-15 Alkyl Lactate, Morus Alba Root Extract, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Safflower Oil/Palm Oil Aminopropanediol Esters, PPG-5-Laureth-5, Sodium Hydroxide, Kojic Acid, Hydroxypropyl Cyclodextrin, Sophora Angustifolia Root Extract, Disodium EDTA, Polyquaternium-11, Arctostaphylos Uva-Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Allantoin

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Fort Worth, TX 76177

All trademarks are the property of their respective owners

cetaphil.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.

Principle Display Panel 3 Fl Oz Carton (PRINCIPLE DISPLAY PANEL - 3 FL OZ Carton)

Cetaphil®



ACNE

GENTLE CLEAR

Mattifying

Acne

Moisturizer


0.5% Salicylic Acid Acne Treatment



Oil Absorbing moisturizer

provides a matte finish while

clearing breakouts



Salicylic Acid,

Prebiotic



Dermatologist Recommended

Sensitive Skin 



3 FL OZ (89 mL)

Distributed by: Galderma Laboratories, L.P., Dallas TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com

Made in Canada

P56653-3





           


Advanced Ingredient Data


Raw Label Data

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