VITAMIN B5 ESSENCE- dimethicone cream 
NATURE REPUBLIC 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 4.50%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Panthenol, Niacinamide, Pentylene Glycol, Polyglycerin-3, Trehalose, Dipropylene Glycol, Xylitol, Sodium Polyacrylate, Butylene Glycol, Propanediol, Boron Nitride, Phenoxyethanol, PEG/PPG-18/18 Dimethicone, Pyrus Malus (Apple) Fruit Water, Lecithin, Ethylhexyl Stearate, Sodium Hyaluronate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Trideceth-6, Madecassoside, Polyglutamic Acid

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: The vitamin B5 essence helps sensitive and dry skin feel moisturized.

DOSAGE & ADMINISTRATION

Dosage & Administration: After using toner, apply an appropriate amount on the entire face and gently pat to promote absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

VITAMIN B5 ESSENCE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.57 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-436-021 in 1 CARTON12/01/2016
1NDC:51346-436-0135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2016
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
NATURE REPUBLIC CO., LTD.631172020relabel(51346-436)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(51346-436)

Revised: 1/2017
Document Id: f1c6ae79-6927-42bc-a2ab-e7e025796aed
Set id: c0d0a5cc-2f1a-4d70-aee4-80099a28107a
Version: 1
Effective Time: 20170119
 
NATURE REPUBLIC CO., LTD.