VITAMIN B5 ESSENCE- dimethicone cream

VITAMIN B5 ESSENCE by

Drug Labeling and Warnings

VITAMIN B5 ESSENCE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

VITAMIN B5 ESSENCE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.57 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-436-02	1 in 1 CARTON	12/01/2016
1	NDC: 51346-436-01	35 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2016

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-436)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(51346-436)