Drug Labeling and Warnings

Drug Details [pdf]

MEFACTORY CEMENT PEEL OFF PACK- glycerin gel 
MeFactory 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 ingredients: Glycerin 2.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Polyvinyl Alcohol, Alcohol, Bentonite, Titanium Dioxide (CI 77891), C12-14 Pareth-12, 1,2-Hexanediol, Charcoal Powder, Xanthan Gum, Salvia Hispanica Seed Extract, Houttuynia Cordata Extract, Canadian Colloidal Clay, Fragrance, Ethylhexylglycerin, Propanediol, Allantoin, Disodium EDTA

PURPOSE

Purpose: Skin Moisturizing

WARNINGS

Warnings: For external use only. 1. Discontinue use immediately and consult a dermatologist, if you experience the following: 1) Irritation, Red spots, itchy skin or rash 2) Applied skin area has the above reaction from direct sun 2. Do not use on irritated skin, cuts, or other infected skin area. 3. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Apply a medium-to-thick layer (2mm) on the desired area where blackhead-removal is required (such as the nose/t-zone). Make sure to avoid eyebrows, hairline, sensitive areas such as around the eyes and lips or anywhere with facial hair such as sideburns. Leave for 15-25 mins making sure it is completely dry & carefully peel away. Finish with a toner. Steam your face for maximum result.

Directions

Directions: Suggested use is 1-2 times a week

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEFACTORY CEMENT PEEL OFF PACK 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70908-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	4.8 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Bentonite (UNII: A3N5ZCN45C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70908-160-02	1 in 1 CARTON	07/01/2017	12/01/2018
1	NDC: 70908-160-01	120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2017	12/01/2018

Labeler - MeFactory Co., Ltd. (689840967)

Registrant - MeFactory Co., Ltd. (689840967)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(70908-160)

Revised: 7/2019

Document Id: ed28d455-e410-42f2-8c2a-9f2d58038c7e

34390-5

Set id: 3458c5fa-9e69-4bb4-b8f0-98d2efcc6ce7

Version: 2

Effective Time: 20190708