CETAPHIL ACNE RELIEF BODY WASH- salicylic acid gel

Cetaphil Acne Relief Body Wash by

Drug Labeling and Warnings

Cetaphil Acne Relief Body Wash by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Fruit of The Earth, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CETAPHIL ACNE RELIEF BODY WASH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4121-00	591 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/01/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth, Inc		080086802	manufacture(0299-4121)