CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS CLEANSER- salicylic acid lotion

CeraVe Developed with Dermatologists Psoriasis Cleanser by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Psoriasis Cleanser by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Psoriasis

Uses

• for the relief of skin itching, scaling, redness, flaking and irritation associated with psoriasis
• helps prevent the recurrence of the symptoms of psoriasis

Warnings

For external use only

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed

Ask doctor before use if

condition covers a large area of the body

Keep out of reach of children.

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

Directions

• for best results use at least twice a week or as directed by a doctor
• wet skin with lukewarm water
• massage cleanser into skin in a gentle circular motion
• rinse

Other information

• keep cap tightly closed when not in use
• store in cool, dry location

Other information

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this proudct and for a week afterwards.

Inactive ingredients

water, glycerin, capryl/capramidopropyl betaine, urea, sodium C14-16 olefin sulfonate, shea butter, amidopropyl betaine, laureth-9, PEG-150 pentaerythrityl tetrastearate, sodium lactate, ethoxydiglycol, niacinamide, gluconolactone, C12-13 alkyl lactate, sodium benzoate, saccharide isomerate, lactic acid, disodium EDTA, sodium lauroyl lactylate, ceramide 3, ceramide 6-II, phytosphingosine, cholesterol, sodium hyaluronate, xanthan gum, carbomer, ceramide 1

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS CLEANSER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-601
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)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
UREA (UNII: 8W8T17847W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SHEA BUTTER (UNII: K49155WL9Y)
POLIDOCANOL (UNII: 0AWH8BFG9A)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
SODIUM LACTATE (UNII: TU7HW0W0QT)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
NIACINAMIDE (UNII: 25X51I8RD4)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-601-01	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/18/2017
2	NDC: 49967-601-02	28 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	08/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/18/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture(49967-601)