RUBELLI BEAUTY FACE- dimethicone, witch hazel patch

Rubelli Beauty Face by

Drug Labeling and Warnings

Rubelli Beauty Face by is a Otc medication manufactured, distributed, or labeled by RUBELLI CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.4%, Hamamelis Virginiana (Witch Hazel) Extract 0.50%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Dipropylene Glycol , Cyclopentasiloxane, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Stearic Acid, Chlorphenesin, Polyquaternium-51, Glaucine, Carbomer, Sodium Citrate, Phenoxyethanol, Hydrogenated Olive Oil, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Dimethicone/Vinyl Dimethicone Crosspolymer, Hedera Helix (Ivy) Leaf/Stem Extract, Allantoin, Polysorbate 80, PVM/MA Copolymer, Sodium Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ubiquinone, Adenosine, Disodium EDTA, Vanillyl Butyl Ether, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

1. Please consult with a physician or other qualified health provider if you have abnormal symptoms such as red spot, swelling or itching, or side effects caused by exposure to direct sunlight, during or after use of the product. 2. Avoid areas with wounds or other sensitive areas. 3. Precautions for storage and handling. 1)Keep out of reach of children. 2)Avoid direct exposure to sunlight. 4. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use:

"Beauty Face" provides 3 levels of results with heating effect of Mask Sheet (Warmth) > Strong adhesion using Facial Band> Skin elasticity management to deliver nourishment and firmness to the chin, cheeks and neck skin. Unlike other mask sheets, Rubelli beauty face covers the cheeks, chin and upper neck and the facial band provides tightening effect that can be felt continuously. Use repeatedly for more than 4 ~ 5 times per week to help you manage the your face firmly and smoothly.

Directions

Directions:

1. After cleansing, remove the water and clean the skin. 2. Open the pouch to take out and unfold the mask sheet and apply to your face in a V shape along the jaw and neckline. 3. Fix the enclosed facial Band around the face, starting from the area that is covered by the mask sheet and slowly wrap around your head to fit your face. 4. After enough rest for about 40 minutes ~ 1 hour, remove the mask sheet and facial band and clean off the remaining essence. 5. There is no need for additional care or cleansing after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUBELLI BEAUTY FACE 
dimethicone, witch hazel patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71006-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.28 g  in 20 mL
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	0.10 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71006-010-02	7 in 1 CARTON	09/01/2016
1	NDC: 71006-010-01	20 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2016

Labeler - RUBELLI CO.,LTD (689452000)

Registrant - RUBELLI CO.,LTD (689452000)

Establishment
Name	Address	ID/FEI	Business Operations
RUBELLI CO.,LTD		689452000	manufacture(71006-010)