CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER- salicylic acid cream

Cetaphil Gentle Clear Clarifying Acne Cleanser by

Drug Labeling and Warnings

Cetaphil Gentle Clear Clarifying Acne Cleanser 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]

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 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

SPL UNCLASSIFIED SECTION

Distributed by:
Galderma Laboratories, L.P.          
Dallas, TX 75201 USA

All trademarks are the property
of their respective owners.

cetaphil.com
P56651-2

PRINCIPAL DISPLAY PANEL - 4.2 FL OZ tube

NEW LOOK
Cetaphil          

Gentle Clear

Clarifying
Acne Cream
Cleanser

2% Salicylic Acid
      Acne Treatment

Deep cleans and exfoliates
to unclog pores preventing
future breakouts

Salicylic Acid, White Tea
& Aloe

Dermatologist Recommended
Sensitive Skin logo

4. 2 FL OZ (124 mL)

INGREDIENTS AND APPEARANCE

CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4119
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4119-00	124 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2021
2	NDC: 0299-4119-05	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 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(0299-4119)