RUBELLI WINE HAND PACKS- glycerin patch 
RUBELLI CO.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 3.0%

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Alcohol, Propylene Glycol, Sodium Hyaluronate, Wine Extract(0.025%), Acacia Concinna Fruit Extract(and)Butylene Glycol(and)Propylene Glycol(and)Betain(and)Water, Methyl Gluceth-20, Vitis Vinifera (Grape) Fruit Extract, Polyglutamic Acid, PEG-40 Hydrogenated Castor Oil, PEG-12 Dimethicone, Eucalyptus Globulus Leaf Extract, Phenoxyethanol, Fragrance, Carbomer, Allantoin, Panthenol, Caffeine, Chlorphenesin, Tocopheryl Acetate, Astaxanthin, Fragaria Chiloensis (Strawberry) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Triethanolamine, Adenosine, Arbutin, Punica Granatum Seed Oil, Disodium EDTA, Ubiquinone

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

1. If following symptoms develop, continuing use of the product might aggravate the symptoms, thus discontinue use and consult a doctor.

1)Red spots, swelling, itching or dermatitis. 2)Above symptoms on the applied area after exposure to direct sunlight.

2. Avoid contact for areas with wounds, eczema or dermatitis.

3.Caution for storage and handling

1) Be sure to put the cap on after use. 2) keep out of reach of children. 3) Keep out of high temperature, low temperature or direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use:

Home care product for easy and convenient hand care at home. Wine extract and grape extract provide ample nutrients for skin’s elasticity, and hyaluronic acid which is known as moisture magnet serves as protective shield for moisture to make rough and dry hands smooth and moist with its superb moisturizing effect. Also, fruit extract helps remove coarse dead skin cells softening hand skin and keeping hands moisturized at all times.

Directions

Directions:

01. Open the pocket and wear “Hand packs” 02. More wear a vinyl once glove. 03. Wine rubber hand around the wrist not to let essence flow out. 04. pull off the product after resting for 30 minutes and deal with the extract remained.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

RUBELLI WINE HAND PACKS 
glycerin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71006-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin1.50 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71006-020-021 in 1 CARTON09/01/2016
1NDC:71006-020-0150 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2016
Labeler - RUBELLI CO.,LTD (689452000)
Registrant - RUBELLI CO.,LTD (689452000)
Establishment
NameAddressID/FEIBusiness Operations
RUBELLI CO.,LTD689452000manufacture(71006-020)

Revised: 10/2016
Document Id: 22a4c65f-a7a3-4be7-812b-12c81ea4c6f9
Set id: b14e4b20-0bcb-4252-ba2d-1d07c73632f0
Version: 1
Effective Time: 20161011
 
RUBELLI CO.,LTD