FDA.reportPublic FDA data

AD1 ECZEMA GEL EBBE SEAWATER ESSENTIALS

Manufacturer
BLUE SEA LABORATORIES SL.
Effective date
2016-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:58

Label at a glance#

ProductEBBE
Active ingredientOATMEAL
Label structure12 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: ■ Eczema ■ Rashes

Dosage and administration

Apply as needed.

Storage and handling

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to: ■ Eczema ■ Rashes

Warnings

WARNINGS SECTION

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

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.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EBBEEBBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1857943colloidal oatmeal 2 % Topical GelPSN1
1857943colloidal oatmeal 0.02 MG/MG Topical GelSCD1
1857943colloidal oatmeal 2 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71051-101-022020-01-31C16284748780-19d75b9d0-e5ae-f424-e053-dadaa90a57ceAD1 ECZEMA GEL EBBE SEAWATER ESSENTIALS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71051-101-01EBBE100 mL in 1 TUBEGEL1001
71051-101-02EBBE1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71051-101EBBE (COLLOIDAL OATMEAL) GEL [BLUE SEA LABORATORIES SL.]1Legacy NDC, 2 package rows20161111_a66daad1-ca77-445d-a1b0-9ce13dc8a44f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71051-10171051-101-01, 71051-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
ACETYL HEXAPEPTIDE-494055X1S509IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBENOXOLONE SODIUMF1MP7242Z5IACT
GLYCERINPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8657ca1d-09dd-4891-89ae-da053ae78210a66daad1-ca77-445d-a1b0-9ce13dc8a44f2016-11-05WarningsExact identifier
spl id: 8657ca1d-09dd-4891-89ae-da053ae78210
spl set id: a66daad1-ca77-445d-a1b0-9ce13dc8a44f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.