Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE LIPIKAR ECZEMA SOOTHING RELIEF- oatmeal cream

  • NDC Code(s): 49967-621-01, 49967-621-02, 49967-621-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes
  • Warnings

    For external use only

  • 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, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

  • Questions or comments?

    1-888-LRP LABO

    1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE LIPIKAR ECZEMA SOOTHING RELIEF 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    MANNOSE, D- (UNII: PHA4727WTP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-621-011 in 1 CARTON11/21/201711/21/2017
    15 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-621-02200 mL in 1 TUBE; Type 0: Not a Combination Product11/21/2017
    3NDC:49967-621-031 in 1 CARTON11/21/2017
    33 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/21/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIQUE ACTIVE PRODUCTION282658798manufacture(49967-621) , pack(49967-621)
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