Label: CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS MOISTURIZING- salicylic acid cream

  • NDC Code(s): 49967-701-01, 49967-701-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 9, 2022

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  • 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

    image of a label

  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS PSORIASIS MOISTURIZING 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-701-01227 g in 1 JAR; Type 0: Not a Combination Product08/30/2017
    2NDC:49967-701-025 g in 1 JAR; Type 1: Convenience Kit of Co-Package08/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/30/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc.071609663manufacture(49967-701)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC624244349manufacture(49967-701) , pack(49967-701)
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