CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER- salicylic acid lotion 
Galderma Laboratories, L.P.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Salicylic Acid 0.5%


Purpose
Acne Treatment

Use

● For the management of acne.

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.

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, 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

PRINCIPLE DISPLAY PANEL - 3 FL OZ Carton

#1 Doctor Recommended
Sensitive Skincare Brand
Cetaphil®


GENTLE CLEAR

Mattifying Acne Moisturizer

Salicylic Acid Acne Treatment

Clinically proven technology to
clear acne and help reduce the
appearance of pores

Bisabolol & Prebiotics soothe and
strengthen skin barrier

5 skin sensitivity signs

3 FL OZ (89 mL)

Distributed by: Galderma Laboratories, L.P., Fort Worth TX 76177 USA
All trademarks are the property of their respective owners.
cetaphil.com
P56653-1


           

P56653-1 Cetaphil Mattifying Acne Moisturizer 3oz Carton
CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4117
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)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Dimethicone (UNII: 92RU3N3Y1O)  
Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
Glycerin (UNII: PDC6A3C0OX)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Hydrogenated Polydecene (550 Mw) (UNII: U333RI6EB7)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
Ppg-2 Myristyl Ether Propionate (UNII: 88R97D8U8A)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
.Alpha.-Glucan Oligosaccharide (UNII: S95658MI3W)  
Squalane (UNII: GW89575KF9)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
C12-15 Alkyl Lactate (UNII: GC844VRD7E)  
Morus Alba Root (UNII: CST1G9BZGD)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Levomenol (UNII: 24WE03BX2T)  
Safflower Oil (UNII: 65UEH262IS)  
Ppg-25-Laureth-25 (UNII: 2R54TS98QU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Kojic Acid (UNII: 6K23F1TT52)  
Hydroxypropyl Betadex (UNII: 1I96OHX6EK)  
Sophora Flavescens Root (UNII: IYR6K8KQ5K)  
Edetate Disodium (UNII: 7FLD91C86K)  
Polyquaternium-11 (1000000 Mw) (UNII: 0B44BS5IJS)  
Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)  
Glycyrrhiza Glabra (UNII: 2788Z9758H)  
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Allantoin (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4117-001 in 1 CARTON05/01/2021
189 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:0299-4117-055 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/01/2021
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC dba Voyant Beauty032565959manufacture(0299-4117)

Revised: 5/2022
Document Id: 92d793d7-e719-4251-9687-c719a6a66cff
Set id: 72977030-d9b6-435f-b321-edcbbb731587
Version: 3
Effective Time: 20220512
 
Galderma Laboratories, L.P.