GD11 Rx SCM C5: Package Insert and Label Information

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.

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

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GD11 RX SCM C5
mannitol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62171-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MANNITOL (MANNITOL) MANNITOL 0.10 g in 2 mL
Inactive Ingredients
Ingredient Name Strength
Water
Betaine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62171-100-02 10 CONTAINER in 1 CARTON contains a CONTAINER (62171-100-01)
1 NDC:62171-100-01 2 mL in 1 CONTAINER This package is contained within the CARTON (62171-100-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2017
Labeler — Coson Co., Ltd. (689835593)
Registrant — Coson Co., Ltd. (689835593)
Establishment
Name Address ID/FEI Operations
COSON Co., Ltd._Osan Plant 689847210 manufacture (62171-100)

Revised: 08/2017 Coson Co., Ltd.

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