EBBE- colloidal oatmeal gel

EBBE by

Drug Labeling and Warnings

EBBE by is a Otc medication manufactured, distributed, or labeled by BLUE SEA LABORATORIES SL.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EBBE 
colloidal oatmeal gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71051-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71051-101-02	1 in 1 BOX	11/05/2016
1	NDC: 71051-101-01	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/05/2016

Labeler - BLUE SEA LABORATORIES SL. (466819309)

Establishment
Name	Address	ID/FEI	Business Operations
BLUE SEA LABORATORIES SL.		466819309	manufacture(71051-101)