Label: ROYCEDERM ECZEMA RELIEF CREAM- colloidal oatmeal 1% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 5, 2025

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  • ACTIVE INGREDIENT

    Colloidal Oatmeal 1%

  • PURPOSE

    Skin Protectant

  • DOSAGE & ADMINISTRATION

    Temporarily protects and helps relieve minor skin irritationand itching due to Eczema and Rashes

  • WARNINGS

    For external use only

    do not get into eyes

    condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days

    In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)

  • INDICATIONS & USAGE

    • Conduct a patch test on a small area of skin to checkfor sensitivity or allergic reaction.
    • Apply as needed to affectedarea.
    • Use 1-2 times daily or as directed by a doctor.
    • For childrenunder 6 months of age: ask a doctor.
  • OTHER SAFETY INFORMATION

    store at room temperature. Avoid excessive heat and direct sunlight.

  • INACTIVE INGREDIENT

    Aqua, Butylene Glycol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Camellia Japonica Seed Oil,Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Cetearyl Glucoside, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Ceramide 1, Ceramide 3, Ceramide 6 ll, Ectoin,Carboxymethyl Chitosan, Camellia Sinensis Leaf Extract, Tremella Fuciformis Polysaccharide, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Maltodex-trin, Chrysanthellum Indicum Extract, Houttuynia Cordata ExtractOpuntia Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Allantoin, Sodium Hyaluronate, Sodium Polyglutamate, Centella Asiatica Extract, Madecassoside, Asiaticoside

  • QUESTIONS

    Email service@roycederm.com

  • PRINCIPAL DISPLAY PANEL

    package

  • INGREDIENTS AND APPEARANCE
    ROYCEDERM ECZEMA RELIEF CREAM 
    colloidal oatmeal 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85424-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.13 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    AQUA (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    ECTOIN (UNII: 7GXZ3858RY)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    OAT (UNII: Z6J799EAJK)  
    N-CARBOXYMETHYLCHITOSAN (UNII: 5R88W82CC6)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PURSLANE (UNII: M6S840WXG5)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    SODIUM POLYGLUTAMATE (200000 MW) (UNII: LN8DW52UVL)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)  
    SODIUM HYALURONATE (UNII: YSE9PPT4TH)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALANE (UNII: GW89575KF9)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)  
    OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85424-010-01113 g in 1 CARTON; Type 0: Not a Combination Product09/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/2025
    Labeler - RoyceDerm LLC (130329531)
    Registrant - RoyceDerm LLC (130329531)
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