CELLAPY DR SANITIZER- alcohol gel 
GM Holdings Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Ethanol (Synthetic Alcohol 70%)

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

Glycerin, Propylene Glycol, Carbomer, Camellia Sinesis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Triethanolamine, Citrus Limon (Lemon) Fruit Oil, Water

PURPOSE

PURPOSE: Disinfecting Agent

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

Uses:

Uses : Externally disinfects the hands and skin

WARNINGS

Warnings
For external use only
When using this product if following abnormal symptoms persist, discontinue use
1) Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
a) For external use only (Do not use internally)
b) Avoid getting into the eyes
(if contact occurs, wash well with clean water)
Be careful to not inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
Do not use the product for a long time in the same area as swelling, inflammation may occur or sickness due to absorption through the skin.
It is not recommended to use this one areas that have been medically treated with a cast or bandage.
Do not use in combination with soap or antibacterial cleansing agents.
Precautions
1) Keep out of open flames
2) Keep out of reach of children
3) Do not replace the container with another as quality deterioration or accidents may occur

Directions

Directions:
Pour a small amount onto hands, spready evenly and rub into skin

PACKAGE LABEL - 70mL Tube

Image of tube

PACKAGE LABEL - 500mL Bottle Pump

Image of bottle

CELLAPY DR SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69278-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69278-110-0170 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2020
2NDC:69278-110-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/04/2020
Labeler - GM Holdings Co., Ltd (688439958)
Registrant - GM Holdings Co., Ltd (688439958)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(69278-110)

Revised: 3/2020
Document Id: 0a6a144a-c341-4a4f-92bb-e08331419af2
Set id: 14dde39e-e914-42a6-bf70-8e64d7f29326
Version: 1
Effective Time: 20200320
 
GM Holdings Co., Ltd