Marine Purifying (Panthenol, Allantoin) Patch [Imode Korea, Inc.] -

MARINE PURIFYING (PANTHENOL, ALLANTOIN) PATCH [IMODE KOREA, INC.]
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NDC	71727-102-01, 71727-102-02, 71727-102-03
Set ID	61eb9b86-40d6-ac21-e053-2a91aa0a18da
Category	HUMAN OTC DRUG LABEL
Packager	iMode Korea, Inc.
Generic Name
Product Class
Product Number
Application Number

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Active ingredients

Panthenol (0.6%)

Allantoin (0.3%)
Purpose

Skin protectant
Keep out of reach of children

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

Moisturizes skin.
Warnings
Directions

1) After cleansing, wipe off water using a towel. 2) Open the package and take out the mask. 3) Place the mask around eyes first, and then the rest of face. 4) Relax with the mask on for 15-20 minutes, then remove the sheet. 5) Gently tap the remaining serum onto skin and let it absorb.
Inactive ingredients

Water, Glycerin, Dipropylene Glycol, Castanea Crenata (Chestnut) Shell Extract, Moringa Pterygosperma Seed Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Alcohol, Sodium Hydroxide, Eucalyptus Globulus Leaf Extract, Scutellaria Baicalensis Root Extract, Ethylhexylglycerin, Glyceryl Caprylate, Fucus Vesiculosus Extract, Prunella Vulgaris Extract, Sodium Hyaluronate, Butylene Glycol, PEG-32, Trehalose, Sodium Lactate, PEG-2M, Silica, Sodium Citrate, Xanthan Gum, PEG-60 Hydrogenated Castor Oil, Glyceryl Acrylate/Acrylic Acid Copolymer, Propylene Glycol, Caprylyl Glycol, Caffeine, Hydroxyethylcellulose, Cyclodextrin, Dextrin, Cellulose Gum, Disodium EDTA, Hydroxyacetophenone, Hexylene Glycol, Caprylhydroxamic Acid, Propanediol, Ethyl Hexanediol, 1,2-Hexanediol, Chlorphenesin
MARINE PURIFYING

INGREDIENTS AND APPEARANCE

MARINE PURIFYING
panthenol, allantoin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71727-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.162 mg in 27 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.081 mg in 27 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CASTANEA CRENATA SHELL (UNII: MTF3V701OO)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
PRIMULA VERIS (UNII: W6LFQ57E4M)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71727-102-03	5 in 1 BOX	01/03/2018
1	NDC:71727-102-02	1 in 1 POUCH
1	NDC:71727-102-01	27 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/03/2018

Labeler - iMode Korea, Inc. (694627846)

Registrant - iMode Korea, Inc. (694627846)

Name	Address	ID/FEI	Business Operations
Establishment
JINCOSTECH Co., Ltd.		688484870	manufacture(71727-102)

Name	Address	ID/FEI	Business Operations
Establishment
iMode Korea, Inc.		694627846	relabel(71727-102)

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Medic

MARINE PURIFYING (PANTHENOL, ALLANTOIN) PATCH [IMODE KOREA, INC.]

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