Label: CERAVE DEVELOPED WITH DERMATOLOGISTS THERAPEUTIC HAND- dimethicone cream

  • NDC Code(s): 49967-925-01, 49967-925-02, 49967-925-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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

  • Active ingredient

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Use

    helps prevent and temporarily protects chafed, chapped or cracked skin

  • Warnings

    For external use only

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

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

  • Directions

    apply as needed

  • Inactive Ingredients

    water, cyclopentasiloxane, aluminum/magnesium hydroxide stearate, cyclohexasiloxane, niacinamide, sodium chloride, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, ceramide NP, ceramide AP, ceramide EOP, carbomer, methylparaben, sodium lauroyl lactylate, cholesterol,. Propylparaben, hydrolyzed hyaluronic acid, phytosphingosine, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

  • Questions or comments?

    Toll-free number 1-888-768-2915

    www.cerave.com

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS THERAPEUTIC HAND 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-925
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-925-011 in 1 CARTON12/12/201712/01/2023
    185 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-925-025 g in 1 TUBE; Type 0: Not a Combination Product12/12/201712/01/2023
    3NDC:49967-925-031 in 1 CARTON12/12/2017
    385 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/12/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-925) , pack(49967-925)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC071609663manufacture(49967-925)