OTC Medication Information: Frudia Blueberry Hydrating Mask

FRUDIA BLUEBERRY HYDRATING MASK- lowbush blueberry patch
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 55.29%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Methylpropanediol, Betaine, Glycereth-26, 1,2-Hexanediol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Panthenol, Bis-PEG-18 Methyl Ether Dimethyl Silane, PEG-40 Hydrogenated Castor Oil, Chlorphenesin, Phenoxyethanol, PEG-6 Methyl Ether, Allantoin, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Fragrance, Coco-Caprylate/Caprate, BHT, Prunus Armeniaca (Apricot) Kernel Oil, Vitis Vinifera (Grape) Seed Oil, 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: 1. Apply toner after a face wash. 2. Open the pouch, and apply mask with the film liner to fit it evenly on the face and discard the film liner. 3. Leave on for 10-20 minutes. Remove mask and gently pat remaining serum until fully absorbed.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use the mask sheet every day

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRUDIA BLUEBERRY HYDRATING MASK lowbush blueberry patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71017-050 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOWBUSH BLUEBERRY (LOWBUSH BLUEBERRY) LOWBUSH BLUEBERRY 14.9 g in 27 mL

Inactive Ingredients Ingredient Name Strength Water Methylpropanediol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71017-050-01 27 mL in 1 POUCH None

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 (71017-050)

Revised: 11/2016 WELCOS CO.,LTD.