Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3e6eb59f-c523-460e-87ed-750b4a8cacac
Route
TOPICAL
Published
Effective Date 2023-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Water Glycerin Coco-caprylate/caprate Gluconolactone Propanediol Sodium Hydroxide Succinic Acid Panthenol Niacinamide Lysophosphatidylcholine, Soybean Betasizofiran Zinc Gluconate Pullulan Xanthan Gum Pantolactone, (r)- Citric Acid Monohydrate Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Salicylic Acid 0.5% 

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 0.5% 

Uses

For the management of acne                 

Section 50565-1

Keep out of reach of children.

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

Section 53413-1

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com.

P56577-1



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 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 Ingredients

Salicylic Acid 0.5% 

Inactive Ingredients

WATER, GLYCERIN, COCO-CAPRYLATE/CAPRATE, GLUCONOLACTONE, PROPANEDIOL, SODIUM HYDROXIDE, SUCCINIC ACID, PANTHENOL, NIACINAMIDE, LYSOLECITHIN, SCLEROTIUM GUM, ZINC GLUCONATE, PULLULAN, XANTHAN GUM, PANTOLACTONE, CITRIC ACID, SILICA

Questions Or Comments?

1-866-735-4137

Principle Display Panel  1 Fl Oz Carton

NEW LOOK



Cetaphil®                 

ACNE

GENTLE CLEAR

Triple-Action

Acne Serum



0.5% Salicylic Acid Acne Treatment







Hydrates, soothes and

resurfaces to visibly improve

breakouts in 3 days



Salicylic Acid,

Niacinamide

& Prebiotic 



Dermatologist Recommended

Sensitive Skin



1 FL OZ (30 mL)


















Structured Label Content

Uses

For the management of acne                 

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 53413-1 (53413-1)

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com.

P56577-1



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 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 Ingredients

Salicylic Acid 0.5% 

Inactive Ingredients

WATER, GLYCERIN, COCO-CAPRYLATE/CAPRATE, GLUCONOLACTONE, PROPANEDIOL, SODIUM HYDROXIDE, SUCCINIC ACID, PANTHENOL, NIACINAMIDE, LYSOLECITHIN, SCLEROTIUM GUM, ZINC GLUCONATE, PULLULAN, XANTHAN GUM, PANTOLACTONE, CITRIC ACID, SILICA

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Principle Display Panel  1 Fl Oz Carton (Principle Display Panel - 1 FL OZ Carton)

NEW LOOK



Cetaphil®                 

ACNE

GENTLE CLEAR

Triple-Action

Acne Serum



0.5% Salicylic Acid Acne Treatment







Hydrates, soothes and

resurfaces to visibly improve

breakouts in 3 days



Salicylic Acid,

Niacinamide

& Prebiotic 



Dermatologist Recommended

Sensitive Skin



1 FL OZ (30 mL)


















Advanced Ingredient Data


Raw Label Data

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