ALOE PROPOLIS SOOTHING- allantoin gel
BENTON KOREA

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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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

Image of carton

ALOE PROPOLIS SOOTHING
allantoin gel

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69998-100-02	1 in 1 CARTON	07/01/2016	12/30/2017
1	NDC:69998-100-01	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2016	12/30/2017

Labeler - BENTON KOREA (689514965)

Registrant - BENTON KOREA (689514965)

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

Revised: 5/2023

Document Id: 45d3c90b-7832-445c-bb77-e6dee9333635

Set id: 946f4d89-4fc3-4a82-862b-707b04f0ad26

Version: 2

Effective Time: 20230526

BENTON KOREA