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VITAMIN B5 ESSENCE

Dosage form: cream
Ingredients: Dimethicone 1.57g in 35mL
Labeler: NATURE REPUBLIC CO., LTD.
NDC Code: 51346-436

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 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

VITAMIN B5 ESSENCE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-436
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone1.57 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:51346-436-021 BOTTLE, PUMP in 1 CARTON
1NDC:51346-436-0135 mL in 1 BOTTLE, PUMP
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/FEIOperations
NATURE REPUBLIC CO., LTD.631172020relabel(51346-436)
Establishment
NameAddressID/FEIOperations
Cosmax, Inc689049693manufacture(51346-436)

Revised: 01/2017
 
NATURE REPUBLIC CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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