Drug Labeling and Warnings

Drug Details [pdf]

ANYPACK PEARL TENCEL MASK- glycerin patch 
JINCOSTECH 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.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 7.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Dipropylene Glycol, Glucose, Pearl Powder, PEG-32, Butyrospermum Parkii (Shea Butter), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cellulose Gum, Arginine, Ceratonia Siliqua Gum, Sodium Polyacrylate, Cetyl Ethylhexanoate, Polyglutamic Acid, Allantoin, Sericin, PEG-60 Hydrogenated Castor Oil, Fragrance, Citrus Grandis (Grapefruit) Seed Extract, Glycerin, Bambusa Textilis Stem Extract, Pinus Palustris Leaf Extract, Chlorphenesin, Disodium EDTA

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. Stop using and see a doctor in case of suffering from any adverse side effects or skin irritation as follows while using this product. a)Red spots, edema, itchy sensations, etc., while using. b)In case of having above symptoms due to direct sunlight. Do not place the product directly onto irritated or sunburned skin. 2. Do not use on spots affected by dermatitis and wounds. 3. Do not apply in case of having severe allege reaction to wear sticking plaster or wet patches. 4. Be careful not to get it in your eyes. 5. Cautions for storage and use. a) Use immediately after opening. b) Keep out of reach of children. c) Avoid prolonged exposure to extreme heat or cold and direct sunlight. d) Do not reuse.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: 1. Wash out face and gently pat dry on towel and apply skin toner to increase effectiveness. 2. Take out sheet mask from the pouch. 3. Apply mask with the eyes and lips as the center. 4. Wear for 15~20 minutes and relax. 5. Remove mask and gently stroke face to make remaining essence completely absorbed into the skin.

DOSAGE & ADMINISTRATION

Indications & usage: 1. Wash out face and gently pat dry on towel and apply skin toner to increase effectiveness. 2. Take out sheet mask from the pouch. 3. Apply mask with the eyes and lips as the center. 4. Wear for 15~20 minutes and relax. 5. Remove mask and gently stroke face to make remaining essence completely absorbed into the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANYPACK PEARL TENCEL MASK 
glycerin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70591-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	1.65 g  in 22 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70591-100-02	5 in 1 CARTON	03/02/2016	01/02/2019
1	NDC: 70591-100-01	22 mL in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/02/2016	01/02/2019

Labeler - JINCOSTECH CO.,LTD (688484870)

Registrant - JINCOSTECH CO.,LTD (688484870)

Establishment
Name	Address	ID/FEI	Business Operations
JINCOSTECH CO.,LTD		688484870	manufacture(70591-100)

Revised: 9/2019

Document Id: 337a0338-9a85-4f0c-9094-2015a1904a1c

34390-5

Set id: c9e1109c-64a6-4572-96fa-ef219e97e5b3

Version: 2

Effective Time: 20190905

 

JINCOSTECH CO.,LTD