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Frudia Blueberry Hydrating

Dosage form: cream
Ingredients: Dimethicone 1.39g in 55g
Labeler: WELCOS CO.,LTD.
NDC Code: 71017-010

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 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

FRUDIA BLUEBERRY HYDRATING 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71017-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone1.39 g  in 55 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Packaging
#Item CodePackage Description
1NDC:71017-010-021 BOTTLE, GLASS in 1 CARTON
1NDC:71017-010-0155 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2016
Labeler - WELCOS CO.,LTD. (689131584)
Registrant - WELCOS CO.,LTD. (689131584)
Establishment
NameAddressID/FEIOperations
WELCOS CO.,LTD.689131584manufacture(71017-010)

Revised: 11/2016
 
WELCOS 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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