CETAPHIL ACNE RELIEF BODY WASH- salicylic acid gel 
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.

----------

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 is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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

Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER

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

PRINCIPAL DISPLAY PANEL - 20 FL OZ bottle

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®          

ACNE RELIEF
BODY WASH

Acne-Prone Skin

Maximum strength
OTC formula
to eliminate breakouts

24 hour dryness relief

Advanced Moisture Blend
2% Salicylic Acid
Acne Treatment

5 skin sensitivity signs
20 FL OZ (591 mL)
P55982-1

Cetaphil Acne Relief BodyWash Front Back Labels
CETAPHIL ACNE RELIEF BODY WASH 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4121
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
Benzyl Alcohol (UNII: LKG8494WBH)  
Shea Butter (UNII: K49155WL9Y)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Glycerin (UNII: PDC6A3C0OX)  
Soybean Oil (UNII: 241ATL177A)  
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A)  
Hydrogenated Soybean Oil (UNII: A2M91M918C)  
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
Lauric Acid (UNII: 1160N9NU9U)  
Palmitic Acid (UNII: 2V16EO95H1)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sodium Lauroyl Glycinate (UNII: L54QIO80PN)  
Sodium Lauroyl Isethionate (UNII: M590021Z02)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Edetate Sodium (UNII: MP1J8420LU)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4121-00591 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2022
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of The Earth, Inc080086802manufacture(0299-4121)

Revised: 8/2022
Document Id: dd15d6a5-71fe-4e44-8f55-21d69ca33ed7
Set id: a7c9d509-6f3d-4963-a358-18562f0f2744
Version: 2
Effective Time: 20220801
 
Galderma Laboratories, L.P.