Active ingredients

Step 1 Serum - Allantoin (0.1%)

Step 2 Bio-cellulose mask - Niacinamide (3%), Panthenol (0.1%), Allantoin (0.1%)

Step 3 Cream - Niacinamide (3%), Allantoin (0.1%)

Purpose

Skin portectant

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

Step 1 Serum - Moisturize skin.

Step 2 Bio-cellulose mask - Moisturize skin. Wrinkle care.

Step 3 Serum - Moisturize skin.

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

do not apply on other parts of the body
do not use on damaged or broken skin
avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
do not apply directly to wound or open cut

Stop use and ask a doctor if

Rash or irritation on skin develops and lasts

Directions

Step 1 Serum - After cleanse face, apply toner. Apply ‘step1’ and pat gently.

Step 2 Bio-cellulose mask - After applying ‘step1’, open ‘step2’ sheet mask and remove the non-woven fabric. Adjusting around the eye and mouth area and then remove the other side of the sheet. Leave it on for 15-20 minutes. Remove sheet mask and gently pat remaining serum in until fully absorbed.

Step 3 Serum - After applying ‘step2’, apply ‘step3’ and pat gently.

Step 1 Serum - Aqua, Cyclopentasiloxane, Dipropylene Glycol, Glycerin, Glycereth-26, Bis-PEG-18 Methyl Ether Dimethyl Silane, Benzyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Carbomer, Triethanolamine, Raspberry Ketone, Butylene Glycol, Fragrance, Disodium EDTA, Leontopodium Alpinum Callus Culture Extract, Hydrolyzed Collagen, Phenoxyethanol, Caprylyl Glycol, 1,2-Hexanediol

Step 2 Bio-cellulose mask - Aqua, Dipropylene Glycol, Glycerin, Benzyl Glycol, PEG-60 Hydrogenated Castor Oil, Xanthan Gum, Ethylhexylglycerin, Carbomer, Triethanolamine, Butylene Glycol, Raspberry Ketone, Adenosine, Fragrance, Disodium EDTA, Tocopheryl Acetate, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice Powder, Phenoxyethanol, Leontopodium Alpinum Callus Culture Extract, Hydrolyzed Collagen, Caprylyl Glycol, Maltodextrin, 1,2-Hexanediol

Step 3 Serum - Aqua, Glycerin, Cyclopentasiloxane, Betaine, Caprylic/Capric Triglyceride, Cyclohexasiloxane, Dipropylene Glycol, Hydrogenated Coconut oil, Benzyl Glycol, Sodium Polyacrylate , PEG-60 Hydrogenated Castor Oil, Hydrogenated Polydecene, Ethylhexylglycerin, Xanthan Gum, Trideceth-6, Dimethicone, Tocopheryl Acetate, Raspberry Ketone, Fragrance, Butylene Glycol, Disodium EDTA, Sodium Hyaluronate, Phenoxyethanol, Adenosine, Leontopodium Alpinum Callus Culture Extract, Hydrolyzed Collagen, 1,2-Hexanediol, Caprylyl Glycol

Miracle Of Skin

miracle of skin label draft

MIRACLE OF SKIN
allantoin, niacinamide, pantheon kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72148-103

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72148-103-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	03/15/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	1.5 g
Part 2	1 PATCH	30 g
Part 3	1 BOTTLE	1.5 g

Part 1 of 3

STEP 1 SERUM
allantoin liquid

Product Information
Item Code (Source)	NDC:72148-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	allantoin	0.0015 g in 1.5 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)
Glycerin (UNII: PDC6A3C0OX)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-Hexanediol (UNII: TR046Y3K1G)

#	Item Code	Package Description
Packaging
1	NDC:72148-100-03	4 in 1 PACKAGE
1	NDC:72148-100-02	1 in 1 POUCH
1	NDC:72148-100-01	1.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/15/2018

Part 2 of 3

STEP 2 BIO-CELLULOSE MASK
niacinamide, panthenol, allantoin patch

Product Information
Item Code (Source)	NDC:72148-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.9 g in 30 g
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.03 g in 30 g
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.03 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)
Glycerin (UNII: PDC6A3C0OX)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)
Xanthan Gum (UNII: TTV12P4NEE)
Ethylhexylglycerin (UNII: 147D247K3P)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
Butylene Glycol (UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Phenoxyethanol (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Maltodextrin (UNII: 7CVR7L4A2D)
1,2-Hexanediol (UNII: TR046Y3K1G)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)

#	Item Code	Package Description
Packaging
1	NDC:72148-101-02	1 in 1 POUCH
1	NDC:72148-101-01	30 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
2	NDC:72148-101-03	4 in 1 PACKAGE
2	NDC:72148-101-01	30 g in 1 PATCH; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/15/2018

Part 3 of 3

STEP 3
niacinamide, allantoin cream

Product Information
Item Code (Source)	NDC:72148-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.045 g in 1.5 g
allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	allantoin	0.0015 g in 1.5 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Betaine (UNII: 3SCV180C9W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
Dipropylene Glycol (UNII: E107L85C40)
Hydrogenated Coconut oil (UNII: JY81OXM1OM)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
Ethylhexylglycerin (UNII: 147D247K3P)
Xanthan Gum (UNII: TTV12P4NEE)
Trideceth-6 (UNII: 3T5PCR2H0C)
Dimethicone (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
Butylene Glycol (UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Phenoxyethanol (UNII: HIE492ZZ3T)
Adenosine (UNII: K72T3FS567)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)

#	Item Code	Package Description
Packaging
1	NDC:72148-102-02	1 in 1 POUCH
1	NDC:72148-102-01	1.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC:72148-102-03	4 in 1 PACKAGE
2	NDC:72148-102-01	1.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/15/2018

Labeler - Areum, Inc. (081077378)

Registrant - Areum, Inc. (081077378)

Name	Address	ID/FEI	Business Operations
Establishment
Areum, Inc.		081077378	relabel(72148-103)

Name	Address	ID/FEI	Business Operations
Establishment
Beauty Cosmetic Co., Ltd.		688305761	manufacture(72148-103)