Water Balance Sheet Mask: Package Insert and Label Information

WATER BALANCE SHEET MASK- glycerin patch
MIGUHARA

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: Glycerin 10.0%

INACTIVE INGREDIENT

Inactive Ingredients: Camellia Sinensis Leaf Water, Xanthan Gum, Dipropylene Glycol, Betaine, Sodium Hyaluronate, Beta-Glucan, Aqua, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Butylene Glycol, Hydrolyzed Collagen, PEG-60 Hydrogenated Castor Oil, Bacillus/Houttuynia Cordata Extract Ferment Filtrate, Phenoxyethanol, Allantoin, Ethylhexylglycerin, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Foeniculum Vulgare (Fennel) Oil, Rose Flower Oil, 1,2-Hexanediol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Usage

Usage:

1. put skin or toner after washing up 2. open sheet mask and apply it tightly on the face. 3. remove it within 15 ~ 20 minutes after applying 4. pat gently until absorbed. 5. It is recommendable to use it 2 ~ 3times a week and store it in fridge before using.

Usage

Usage:

1. put skin or toner after washing up 2. open sheet mask and apply it tightly on the face. 3. remove it within 15 ~ 20 minutes after applying 4. pat gently until absorbed. 5. It is recommendable to use it 2 ~ 3times a week and store it in fridge before using.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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WATER BALANCE SHEET MASK
glycerin patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70380-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (GLYCERIN) Glycerin 2.3 g in 23 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF
Xanthan Gum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70380-030-01 23 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/02/2016
Labeler — MIGUHARA (689204213)
Registrant — MIGUHARA (689204213)
Establishment
Name Address ID/FEI Operations
MIGUHARA 689204213 manufacture (70380-030)

Revised: 02/2016 MIGUHARA

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