O2 BUBBLE PACK WASH- dimethicone liquid

O2 Bubble Pack Wash by

Drug Labeling and Warnings

O2 Bubble Pack Wash by is a Otc medication manufactured, distributed, or labeled by Seindni Co.,ltd, PICOSTECH Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water,Sodium Laureth Sulfate,Cocamidopropyl,Betaine,Disodium Cocoamphodipropionate,PEG-7 Glyceryl Cocoate,Acrylates Copolymer,Acrylates/Beheneth-25 Methacrylate Copolymer,Methyl Perfluorobutyl Ether,Methyl Perfluoroisobutyl Ether,Polyhydroxystearic Acid,Ethylhexyl Isononanoate,Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate,Isononyl Isononanoate,Snail Secretion Filtrate, Glycerin,Psidium Guajava Fruit Extract,Litchi Chinensis Fruit Extract,Mangifera Indica (Mango) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract,Nephelium Lappaceum Extract,Carica Papaya (Papaya) Fruit Extract,Fragrance,Potassium Alum,Pearl Powder,Xanthan Gum,Potassium Hydroxide,Trisodium EDTA, Papain,Methylchloroisothiazolinone,Methylisothiazolinone

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning:
1. In case of having following symptoms after using this, 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: After cleansing, pump three times and roll on the dry face avoiding eye area. Rinse off with lukewarm water after 5 minutes.

DOSAGE AND ADMINISTRATION

Dosage and Administration : Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O2 BUBBLE PACK WASH 
dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69072-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Betaine (UNII: 3SCV180C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69072-030-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2014

Labeler - Seindni Co.,ltd (557837682)

Registrant - Seindni Co.,ltd (557837682)

Establishment
Name	Address	ID/FEI	Business Operations
PICOSTECH Co.,Ltd.		557816754	manufacture(69072-030)