FRUDIA BLUEBERRY HYDRATING- dimethicone cream

Frudia Blueberry Hydrating by

Drug Labeling and Warnings

Frudia Blueberry Hydrating by is a Otc medication manufactured, distributed, or labeled by WELCOS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 2.54%

INACTIVE INGREDIENT

Inactive Ingredients: Vaccinium Angustifolium (Blueberry) Fruit Extract, Glycerin, Water, 1,2-Hexanediol, Diglycerin, Methylpropanediol, PEG/PPG-17/6 Copolymer, Betaine, Trisiloxane, Bis-PEG-18 Methyl Ether Dimethyl Silane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Dimethicone/Vinyl Dimethicone Crosspolymer, Panthenol, Phenoxyethanol, PEG-6 Methyl Ether, Ethylhexylglycerin, Polyglyceryl-10 Laurate, Xanthan Gum, Biosaccharide Gum-1, Disodium EDTA, Fragrance, Isoceteth-10, Isoceteth-25, Sodium Hyaluronate, BHT, Coco-Caprylate/Caprate, Prunus Armeniaca (Apricot) Kernel Oil, Vitis Vinifera (Grape) Seed Oil, CI 60730, Citrus Paradisi (Grapefruit) Seed Oil, Mangifera Indica (Mango) Seed Oil, Punica Granatum Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopherol

PURPOSE

Purpose: Skin hydrating

WARNINGS

Warnings: 1. Discontinue use if irritation occurs as follows while using beauty products, and consult a dermatologist as symptoms may worsen if you continue to use: 1) In the case of red spots, swelling, itchiness, irritation etc. while using 2) In the case of the above signs appear on the applied areas being exposed to direct sunlight 2. Avoid applying to abnormal areas including the wound or eczema and dermatitis etc. 3. Warnings in handling and storage 1) Keep the lid closed after using 2) Keep out of infants and children 3) Don't store it in a place of high or low temperature and keep out of direct sunlight

KEEP OUT OF REACH OF CHILDREN

Keep out of infants and children

INDICATIONS & USAGE

Indications & usage: At the last step of skin care, apply the product onto face until absorbed to create a protective moisturizing barrier.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product. Use it twice a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRUDIA BLUEBERRY HYDRATING 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71017-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.39 g  in 55 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71017-010-02	1 in 1 CARTON	10/01/2016
1	NDC: 71017-010-01	55 g in 1 BOTTLE, GLASS; 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	10/01/2016

Labeler - WELCOS CO.,LTD. (689131584)

Registrant - WELCOS CO.,LTD. (689131584)

Establishment
Name	Address	ID/FEI	Business Operations
WELCOS CO.,LTD.		689131584	manufacture(71017-010)