BLACK CAVIDIOL MASK- allantoin patch 
ZEMNA COMPANY CO., Ltd

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 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Propanediol, Methylpropanediol, Butylene Glycol, Caviar Extract, Pearl Powder, Hydroxyethylcellulose, Glyceryl Acrylate/Acrylic Acid Copolymer, Propylene Glycol, PVM/MA Copolymer, Trehalose, Carbomer, Arginine, Disodium EDTA, Allantoin, Dipotassium Glycyrrhizate, Sodium Hyaluronate, Chlorphenesin, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Zingiber Officinale (Ginger) Root Extract, Camellia Sinensis Leaf Extract, Citrus Grandis (Grapefruit) Seed Extract, Acorus Calamus Root Extract, Perilla Ocymoides Leaf Extract, Agar, Xanthan Gum, Algin, Phenoxyethanol, Iron Oxides, Hydrolyzed Keratin

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 2. Do not use the product on an open skin wound or on areas of eczema or infection. 3. Storage and handling instructions 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun. 4. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: 1) Apply a Black Cavidiol Mask onto clean skin and align it evenly onto the face. 2) Pull the bottom of the mask upward and align it evenly with the chin. 3) Remove after 10-20 minutes and lightly tap the skin until the serum is fully absorbed.

DOSAGE & ADMINISTRATION

Dosage and administration: Every day or every other day

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BLACK CAVIDIOL MASK 
allantoin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70768-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.2 g  in 40 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70768-010-021 in 1 CARTON05/01/2016
1NDC:70768-010-0140 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2016
Labeler - ZEMNA COMPANY CO., Ltd (689846931)
Registrant - ZEMNA COMPANY CO., Ltd (689846931)
Establishment
NameAddressID/FEIBusiness Operations
ZEMNA COMPANY CO., Ltd689846931manufacture(70768-010)

Revised: 6/2016
Document Id: 73fef23b-5f3c-4239-aed6-155971e45f7d
Set id: b752b665-b212-4caf-852f-dd873b7dd315
Version: 1
Effective Time: 20160624
 
ZEMNA COMPANY CO., Ltd