Label: PURE BIOLOGY ECZEMA WITH COLLOIDAL OATMEAL- oatmeal cream

  • NDC Code(s): 79217-158-01
  • Packager: Pure Biology Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 30, 2020

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

  • Drug Facts:

  • Active Ingredient

    Colloidal Oatmeal 1%

    Purpose

    Skin Protectant

  • Indications:

    Temporarily protects and helps relieve minor skin irritation and itching to due to Eczema or rashes.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.

    Stop use and ask a doctor if:

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

    Keep out of reach of children.

    • If swallowed, consult physician.
  • Directions:

    • Adults and children two-years of age or older: Apply as needed
    • Children under two-years of age: consult a physician.
  • Additional Information:

    for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

  • Other Ingredients:

    Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    PURE BIOLOGY ECZEMA WITH COLLOIDAL OATMEAL 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79217-158
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79217-158-01115 mL in 1 JAR; Type 0: Not a Combination Product06/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/14/2020
    Labeler - Pure Biology Products LLC (072418922)