Label: SERAWISE ECZEMA RESCUE- oatmeal cream

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

Drug Label Information

Updated December 18, 2024

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  • Drug Facts

  • Active ingredient

    Colloidal oatmeal 1%

    Purpose

    Skin protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching duee to:

    • rashes
    • eczema
    • poison ivy, oak, or sumac 
    • insect bites
  • Warnings

    For external use only

    When using this product

    • do not get into eyes.

    Stop use and consult 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions

    Apply as Needed

  • Other Information

    Keep away from excessive heat and direct sun.

  • Inactive Ingredients

    Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

  • Package Labeling:

    Outer Label.jpgInner Label.jpg

  • INGREDIENTS AND APPEARANCE
    SERAWISE ECZEMA RESCUE 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85050-575
    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
    BEESWAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    CETEARETH-20 (UNII: YRC528SWUY)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85050-575-001 in 1 BOX12/02/2024
    1118.29 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/02/2024
    Labeler - DrAnaMaria.com LLC (122027135)
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