Label: EBBE- colloidal oatmeal gel

  • 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 November 5, 2016

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

  • Drug Facts

  • Active ingredients

    Colloidal Oatmeal 2%

  • 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 the 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 immediately.

  • Directions

    Apply as needed.

  • Inactive ingredients

    acetyl hexapeptide-49, aloe barbadensis (aloe vera) leaf juice, caprylhydroxamic acid, caprylyl glycol, disodium succinoyl glycyrrhetinate, glycerin, hyaluronic acid, seawater, sodium hydroxide, tetrasodium EDTA, xanthan gum

  • Other information

    For use on mild to moderate eczema or as directed by a physician. Store at room temperature. You may report serious side effects to the phone number provided under Questions? below.

  • Questions? Call

    844-EBBE-866

  • SPL UNCLASSIFIED SECTION

    INSTRUCTIONS FOR USE: Apply to the affected area twice daily (or as needed) and massage gently.

    Store in cool, dry place

    AD1 ATOPIC DERMATITIS GEL

    Atopic dermatitis is a skin alteration that consists of dry, flaky and irritated skin.

    EBBE atopic dermatitis gel (AD1) hydrates and provides the emollience required to balance and restore the cutaneous barrier function.

    The high molecular weight hyaluronic acid forms a protective film over the skin’s surface layers, thereby reducing the loss of transepidermal water and providing intense and prolonged hydration.

    The formula contains ultra-purified seawater with more than 75 minerals and trace elements.

    EBBE atopic dermatitis gel (AD1) reduces itching and flaking, whilst improving the skin’s hydration and elasticity.

    The light texture is absorbed quickly.

    Specially indicated for sensitive areas such as face, scalp, and groin.

    Suitable for use on adults and children.

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Blue Sea Cosmetics Inc.

    Tiburon, CA 94920

    www.blueseacosmetics.com

    Made in Spain

  • Packaging

    EBBE

  • INGREDIENTS AND APPEARANCE
    EBBE 
    colloidal oatmeal gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71051-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBENOXOLONE SODIUM (UNII: F1MP7242Z5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71051-101-021 in 1 BOX11/05/2016
    1NDC:71051-101-01100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/05/2016
    Labeler - BLUE SEA LABORATORIES SL. (466819309)
    Establishment
    NameAddressID/FEIBusiness Operations
    BLUE SEA LABORATORIES SL.466819309manufacture(71051-101)