MOIST MOISTURE EYE- 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.

----------

ACTIVE INGREDIENT

Active Ingredients: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Snail Secretion Filtrate, Glycerin, Butylene Glycol,Hydrogenated Polydecene,Cyclopentasiloxane, Cyclohexasiloxane,Caprylic/Capric Triglyceride,Cetearyl Alcohol,Butyrospermum Parkii(Shea Butter), Betaine,Glyceryl Stearate,PEG-40 Stearate,Stearic Acid,Sorbitan Stearate,Beeswax,Hydrolyzed Collagen, Hydrolyzed Keratin,Hydrolyzed Elastin,Methylparaben,Phenoxyethanol,Synthetic Wax,Carbomer,Fragrance, PEG -100 Stearate,Tocopheryl Acetate,Propylparaben,Hydrogenated Lecithin,Ceramide 3,Xanthan Gum, Potassium Hydroxide,Trisodium EDTA,Sodium Hyaluronate

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 lotion, take appropriate amount on the ring fingers and gently pat on the eye area by drawing circles.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MOIST MOISTURE EYE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69072-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.35 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69072-050-0135 g in 1 CARTON; 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(69072-050)

Revised: 12/2018
Document Id: f31c4c82-04eb-4a9b-94b4-2271a2d69642
Set id: 9da033d5-a326-4b63-a950-5fb36d212088
Version: 2
Effective Time: 20181210
 
Seindni Co.,ltd