NANO GOLD BIO MASK PACK- allantoin patch 
AMAROS 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, Butylene Glycol, Glycerin, Betaine, Hamamelis Virginiana (Witch Hazel) Extract, Portulaca Oleracea Extract, Alcohol, Sodium Hyaluronate, Arbutin, Beta-Glucan, Camellia Sinensis Leaf Extract, Polyacrylamide, C13-14 Isoparaffin,Laureth-7, PEG-40 Hydrogenated Castor Oil, Cyclopentasiloxane, Psoralea Corylifolia Fruit Extract, Tocopheryl Acetate, Caprylyl Glycol, Caprylhydroxamic Acid, Triethanolamine, Sodium Chondroitin Sulfate, Squalane, Citrus Grandis (Grapefruit) Seed Extract, Centella Asiatica Extract, Hydrolyzed Collagen, Dipotassium Glycyrrhizate, Melia Azadirachta Extract, Gold, Fragrance.

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, 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 AND USAGE

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening after washing face.

DOSAGE AND ADMINISTRATION

Dosage and Administration: Apply Nano Gold Bio Sheet Mask Pack 1 or 2 times per week. After cleansing, dry face and soothe face with toner. Gently apply the mask to fit the contours of your face. Leave on for 20-30min. Peel off the mask and massage the remaining essence over face. Before using, keep the package in the refrigerator to enjoy a refreshing, cooling mask.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

NANO GOLD BIO MASK PACK 
allantoin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60899-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.17 mg  in 35 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60899-020-0135 mL in 1 CARTON; Type 0: Not a Combination Product09/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2013
Labeler - AMAROS CO., LTD. (690338801)
Registrant - AMAROS CO., LTD. (690338801)
Establishment
NameAddressID/FEIBusiness Operations
AMAROS CO., LTD.690338801manufacture(60899-020)

Revised: 4/2019
Document Id: 39b8c852-5b74-4250-97ae-eef5f7032d74
Set id: 5e60c533-5a3b-49d1-9873-74e92048a627
Version: 2
Effective Time: 20190411
 
AMAROS CO., LTD.