CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER- salicylic acid cream 
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 2%

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 become severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to dampened skin and gently massage, avoiding the eye area. Rinse thoroughly and pat dry. Designed for twice daily use. Can be used less frequently if dryness occurs.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Sodium Methyl Cocoyl Taurate, Sodium Chloride, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract

Distributed by: Galderma Laboratories, L.P.          
Fort Worth, TX 76177 USA
cetaphil.com

PRINCIPAL DISPLAY PANEL - 4.2 FL OZ tube

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil          

Gentle Clear

Clarifying Acne
Cream Cleanser

Salicylic Acid
Acne Treatment

Deep cleans without
over-drying

Immediately starts
working to clear acne
and to help prevent
future breakouts

White Tea &
Aloe Soothe Skin

5 skin sensitivity signs
4. 2 FL OZ (124 mL)

Carton artwork P56561-0
CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)  
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
Sodium Chloride (UNII: 451W47IQ8X)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Edetate Disodium (UNII: 7FLD91C86K)  
Isopropyl Alcohol (UNII: ND2M416302)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4119-00124 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
2NDC:0299-4119-055 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(0299-4119)

Revised: 2/2022
Document Id: afa4a9da-3885-45b6-86db-b783df0d2fa8
Set id: 9add83f2-7da6-4cd0-b91b-f6c937a56255
Version: 2
Effective Time: 20220223
 
Galderma Laboratories, L.P.