CERAVE DEVELOPED WITH DERMATOLOGISTS ACNE CONTROL ACNE TREATMENT- salicylic acid gel

CeraVe Developed with Dermatologists Acne Control Acne Treatment by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Acne Control Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products 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

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

store at 20 – 25ºC (68 – 77ºF)
protect from excessive moisture

Inactive ingredients

water, glycerin, sodium hydroxide, glycolic acid, lactic acid, niacinamide, ceramide NP, ceramide AP, ceramide EOP, carbomer, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, chlorphenesin, disodium EDTA, hydroxypropyl guar, caprylyl glycol, xanthan gum, phytosphingosine, benzoic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS ACNE CONTROL ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-172
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)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCOLIC ACID (UNII: 0WT12SX38S)
LACTIC ACID (UNII: 33X04XA5AT)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-172-01	1 in 1 CARTON	05/18/2021
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/18/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-172) , pack(49967-172)