CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM- salicylic acid solution

Cetaphil Gentle Clear Triple-Action Acne Serum by

Drug Labeling and Warnings

Cetaphil Gentle Clear Triple-Action Acne Serum by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Fruit of The Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Salicylic Acid 0.5% 

Purpose

Acne treatment

Uses

For the management 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 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

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.

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.

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

STORAGE AND HANDLING

Questions or comments?

1-866-735-4137

QUESTIONS

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com.
P56577-1

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)

INGREDIENTS AND APPEARANCE

CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)
Gluconolactone (UNII: WQ29KQ9POT)
Propanediol (UNII: 5965N8W85T)
Sodium Hydroxide (UNII: 55X04QC32I)
Succinic Acid (UNII: AB6MNQ6J6L)
Panthenol (UNII: WV9CM0O67Z)
Niacinamide (UNII: 25X51I8RD4)
Lysophosphatidylcholine, Soybean (UNII: CQD833204Z)
Betasizofiran (UNII: 2X51AD1X3T)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Pullulan (UNII: 8ZQ0AYU1TT)
Xanthan Gum (UNII: TTV12P4NEE)
Pantolactone, (R)- (UNII: J288D7O0JS)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4135-00	1 in 1 CARTON	05/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0299-4135-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/01/2022

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth, Inc.		080086802	manufacture(0299-4135)