CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER- salicylic acid lotion

Cetaphil Gentle Clear Mattifying Acne Moisturizer by

Drug Labeling and Warnings

Cetaphil Gentle Clear Mattifying Acne Moisturizer by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Cosmetic Essence, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

           

INGREDIENTS AND APPEARANCE

CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4117
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4117-00	1 in 1 CARTON	05/01/2021
1		89 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0299-4117-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2021	05/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/01/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		032565959	manufacture(0299-4117)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4117)