MOIST MOISTURE- dimethicone cream 
Seindni 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 Ingredients: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water,PEG/PPG-17/6 Copolymer,Dipropylene Glycol,Snail Secretion Filtrate,Alcohol,Citrus Paradisi (Grapefruit) Fruit Extract,Carbomer,Triethanolamine,Betaine,Trehalose,1,2-Hexanediol,Phenoxyethanol, Hydrolyzed Collagen,Portulaca Oleracea Extract,Camellia Sinensis Leaf Extract,Fragrance,PEG-40 Hydrogenated Castor oil,Sodium Hyaluronate,Sodium Polyacrylate

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: Apply appropriate amount on the face and gently pat.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of container

MOIST MOISTURE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69072-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3 mg  in 300 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69072-040-01300 mL in 1 CONTAINER; Type 0: Not a Combination Product06/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2014
Labeler - Seindni Co.,ltd (557837682)
Registrant - Seindni Co.,ltd (557837682)
Establishment
NameAddressID/FEIBusiness Operations
PICOSTECH Co.,Ltd.557816754manufacture(69072-040)

Revised: 12/2018
Document Id: b7dd8492-ca30-44eb-a6e1-88761f4f91cd
Set id: 24bf482f-0db6-4d5f-8838-aa7e8aa066e7
Version: 2
Effective Time: 20181210
 
Seindni Co.,ltd