ALOE PROPOLIS SOOTHING- allantoin gel

ALOE PROPOLIS SOOTHING by

Drug Labeling and Warnings

ALOE PROPOLIS SOOTHING by is a Otc medication manufactured, distributed, or labeled by BENTON KOREA, Ezekiel Cosmetics Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Propolis Extract, Glycerin, Pentylene Glycol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Betaine, Arginine, Cucumis Sativus (Cucumber) Fruit Extract, Portulaca Oleracea Extract, Citrus Limon (Lemon) Fruit Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS & USAGE

Indications & Usage: After washing the face, put the skin toner and essence, and then take 1-2g into your palm and evenly apply to the entire face. Please slightly tap to enhance the absorption.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE PROPOLIS SOOTHING 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69998-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69998-100-02	1 in 1 CARTON	07/01/2016
1	NDC: 69998-100-01	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	07/01/2016

Labeler - BENTON KOREA (689514965)

Registrant - BENTON KOREA (689514965)

Establishment
Name	Address	ID/FEI	Business Operations
BENTON KOREA		689514965	repack(69998-100)

Establishment
Name	Address	ID/FEI	Business Operations
Ezekiel Cosmetics Co.		689061889	manufacture(69998-100)