CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS MOISTURIZING- salicylic acid cream

CeraVe Developed with Dermatologists Psoriasis Moisturizing by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Psoriasis Moisturizing 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

apply to affected area one to four times daily or as directed by a doctor

Other information

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

Inactive ingredients

water, urea, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, glycerin, cetyl alcohol, niacinamide, laureth-9, limnanthes alba (meadowfoam) seed oil, PEG-100 stearate, gossypium herbaceum (cotton) seed oil, behentrimonium methosulfate, 1,2-hexanediol, C12-13 alkyl lactate, dimethicone, tasmannia lanceolata fruit/leaf extract, ceramide 3, ceamide 6-II, ceramide 1, phytosphingosine, cholesterol, tocopherol, hydroxyacetophenone, hydrogenated olive oil, glyceryl stearate, disodium EDTA, sodium lauroyl lactylate, xanthan gum, carbomer, sodium hyaluronate, sodium hydroxide

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS MOISTURIZING 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-701
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
NIACINAMIDE (UNII: 25X51I8RD4)
POLIDOCANOL (UNII: 0AWH8BFG9A)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PEG-100 STEARATE (UNII: YD01N1999R)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-701-01	227 g in 1 JAR; Type 0: Not a Combination Product	08/30/2017
2	NDC: 49967-701-02	5 g in 1 JAR; Type 1: Convenience Kit of Co-Package	08/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/30/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture(49967-701)