CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM- salicylic acid solution 
Galderma Laboratories, L.P.

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Drug Facts

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.
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

Questions or comments?

1-866-735-4137

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

triple action serum 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)









CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4135-001 in 1 CARTON05/01/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:0299-4135-055 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00605/01/2022
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of The Earth, Inc.080086802manufacture(0299-4135)

Revised: 11/2023
Document Id: 6ef04144-8863-42f8-8f29-b93a0a5ec996
Set id: 3e6eb59f-c523-460e-87ed-750b4a8cacac
Version: 2
Effective Time: 20231116
 
Galderma Laboratories, L.P.