EBBE- colloidal oatmeal gel 
BLUE SEA LABORATORIES SL.

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.

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AD1 ECZEMA GEL
EBBE SEAWATER ESSENTIALS

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

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.

Distributed by

Blue Sea Cosmetics Inc.

Tiburon, CA 94920

www.blueseacosmetics.com

Made in Spain

Packaging

EBBE

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)

Revised: 11/2016
Document Id: 8657ca1d-09dd-4891-89ae-da053ae78210
Set id: a66daad1-ca77-445d-a1b0-9ce13dc8a44f
Version: 1
Effective Time: 20161105
 
BLUE SEA LABORATORIES SL.