Label: CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER- salicylic acid lotion
- NDC Code(s): 0299-4117-00, 0299-4117-05
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Use
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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.
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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
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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
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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
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INGREDIENTS AND APPEARANCE
CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER
salicylic acid lotionProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 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)