GD11 RX SCM C5- mannitol liquid 
Coson 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: MANNITOL 8.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Human Cord Blood Cell Conditioned Media, Sodium Hyaluronate, Betaine, Trehalose

PURPOSE

Purpose: Skin Moisturizing

WARNINGS

Warnings: For external use only

Caution in usage 1. In case of having problems such as red rash, swollenness, itching, you need to consult a dermatologist. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis 3. Caution for treatment and keeping. - Keep it out of infants or children's reach. - Don't keep it exposed to the direct sunlight

KEEP OUT OF REACH OF CHILDREN

Keep it out of infants or children's reach.

Uses

Uses: Helps skin moisture.

Directions

Directions: Get rid of the cap, replace with the enclosed white plastic cap, take adequate amount apply it gently

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

GD11 RX SCM C5 
mannitol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62171-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL0.10 g  in 2 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Betaine (UNII: 3SCV180C9W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62171-100-0210 in 1 CARTON07/01/2017
1NDC:62171-100-012 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2017
Labeler - Coson Co., Ltd. (689835593)
Registrant - Coson Co., Ltd. (689835593)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(62171-100)

Revised: 8/2017
Document Id: bbc9fd79-64bd-4764-b770-eb6451853a2f
Set id: 64654bc7-b829-430b-a382-eb776f5f0edb
Version: 1
Effective Time: 20170824
 
Coson Co., Ltd.