Label: CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH- hydrocortisone cream

  • NDC Code(s): 49967-108-01, 49967-108-02
  • Packager: L'Oreal USA Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis
    • other uses of this product should only be under the advice and supervision of a doctor
  • Warnings

    For external use only

  • Do not uses

    for the treatment of diaper rash. Consult a doctor.

  • When using this product

    avoid contact with the eyes

  • Stop use and ask a doctor if

    if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

  • Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor
  • Inactive ingredients

    water, cetearyl alcohol, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin

  • Other information

    store at 20° to 25°C (68° to 77°F)

  • Questions

    Toll-free number 1-888-768-2915

    www.CeraVe.com

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DEANOL (UNII: 2N6K9DRA24)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OAT (UNII: Z6J799EAJK)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-108-011 in 1 CARTON11/14/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-108-0214 g in 1 TUBE; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/14/2017
    Labeler - L'Oreal USA Products Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc071609663MANUFACTURE(49967-108)