OTC Medication Information: Frudia Blueberry Hydrating Serum

FRUDIA BLUEBERRY HYDRATING SERUM- lowbush blueberry cream
WELCOS CO.,LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Active Ingredient: Vaccinium Angustifolium (Blueberry) Fruit Extract 71.84%

INACTIVE INGREDIENT

Inactive Ingredients: Glycereth-26, Water, Butylene Glycol, Methylpropanediol, PEG/PPG-17/6 Copolymer, 1,2-Hexanediol, Betaine, Diglycerin, Hydroxyethyl Urea, Bis-PEG-18 Methyl Ether Dimethyl Silane, Panthenol, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone, Lecithin, Tromethamine, PEG-6 Methyl Ether, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Xanthan Gum, Biosaccharide Gum-1, Disodium EDTA, Fragrance, Polysorbate 60, Sorbitan Isostearate, 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: Take out suitable amount of the product and apply it onto face gently for better absorption

DOSAGE & ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FRUDIA BLUEBERRY HYDRATING SERUM
lowbush blueberry cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71017-120
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOWBUSH BLUEBERRY (LOWBUSH BLUEBERRY) LOWBUSH BLUEBERRY 35.92 g in 50 g
Inactive Ingredients
Ingredient Name Strength
Glycereth-26
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71017-120-02 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP (71017-120-01)
1 NDC:71017-120-01 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (71017-120-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/10/2016
Labeler — WELCOS CO.,LTD. (689131584)
Registrant — WELCOS CO.,LTD. (689131584)
Establishment
Name Address ID/FEI Operations
WELCOS CO.,LTD. 689131584 manufacture (71017-120)

Revised: 11/2016 WELCOS CO.,LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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