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

Image of pouch
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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.

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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