Label: ECZEMA INTENSIVE DAILY RELIEF BODY- colloidal oatmeal cream cream

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

Drug Label Information

Updated January 7, 2024

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  • ACTIVE INGREDIENT

    colloidal oatmeal 2%

  • INDICATIONS & USAGE

    Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.

  • PURPOSE

    Skin protectant

  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a poison control center right away.

  • STOP USE

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

  • DOSAGE & ADMINISTRATION

    Apply generously to affected areas.

  • INACTIVE INGREDIENT

    Water/Eau/Aqua, Glycerin, Triheptanoin, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Cetyl Stearate, Caprylyl Caprylate/Caprate, Annona Cherimola Fruit Extract, Glyceryl Stearate, Jojoba Oil/Macadamia Seed Oil Esters, Stearyl Alcohol, Vegetable Oil/Huile Végétale, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Acetyl Glutamine, Lecithin, Lithothamnion Calcareum Extract, Hexapeptide-11, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Folic Acid, Oligopeptide-3, Oligopeptide-1, Oligopeptide-2, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Citric Acid, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Tocopherol, Sodium Citrate, Propanediol, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol.

  • QUESTIONS

    1.866.927.2783

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    ECZEMA INTENSIVE DAILY RELIEF BODY 
    colloidal oatmeal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CETYL STEARATE (UNII: 06RI5UQA7L)  
    CHERIMOYA (UNII: 33WVT714QS)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALENE (UNII: 7QWM220FJH)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ROSEMARY (UNII: IJ67X351P9)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ACEGLUTAMIDE (UNII: 01J18G9G97)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    RICE BRAN (UNII: R60QEP13IC)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CORN OIL (UNII: 8470G57WFM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    SOY STEROL (UNII: PL360EPO9J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FOLIC ACID (UNII: 935E97BOY8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-210-00177 g in 1 TUBE; Type 0: Not a Combination Product01/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/07/2024
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC255106239manufacture(61328-210)
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