CERAVE DEVELOPED WITH DERMATOLOGISTS ACNE CONTROL CLEANSER OIL ABSORBING TECHNOLOGY- salicylic acid gel

CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing Technology by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing Technology by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC., L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

• clears acne blemishes and allows skin to heal
• helps prevent new acne blemishes from forming

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use twice daily
• shake well, wet face, then work product into a lather
• massage onto face avoiding the eyes
• rinse well

Inactive ingredients

water, cocamidopropyl hydroxysultaine, glycerin, sodium lauroyl sarcosinate, niacinamide, sodium methyl cocoyl taurate, PEG-150 pentaerythrityl tetrastearate, gluconolactone, sodium cocoyl isethionate, ceramide NP, ceramide AP, ceramide EOP, carbomer, calcium gluconate, triethyl citrate, sodium hydroxide, sodium benzoate, sodium chloride, sodium lauroyl lactylate, cholesterol, coconut acid, tetrasodium EDTA, caprylyl glycol, hydrolyzed hyaluronic acid, trisodium ethylenediamine disuccinate, hectorite, phytosphingosine, xanthan gum, acrylates copolymer, benzoic acid

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS ACNE CONTROL CLEANSER OIL ABSORBING TECHNOLOGY 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-840
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)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HECTORITE (UNII: 08X4KI73EZ)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
COCONUT ACID (UNII: 40U37V505D)
EDETATE SODIUM (UNII: MP1J8420LU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
CERAMIDE NP (UNII: 4370DF050B)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
HYALURONIC ACID (UNII: S270N0TRQY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-840-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
2	NDC: 49967-840-02	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	03/31/2023

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		960317444	manufacture(49967-840) , pack(49967-840)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	manufacture(49967-840) , pack(49967-840)