GIO SOLUTION SANITIZER- ethanol synthetic alcohol gel 
GREEN WONIL 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.

----------

ACTIVE INGREDIENT

Ethanol (Synthetic Alcohol) 70%

INACTIVE INGREDIENT

Water, Glycerin, Carbomer, Chamomilla Recutita (Matricaria) Extract, Eucalyptus Globulus Leaf Extract, Aminomethyl Propanol

PURPOSE

Disinfecting Agent

WARNINGS

For external use only. Flammable. Keep away from heat or flame


When using this product
if following abnormal symptoms persist, discontinue use. lrritation 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 lrritation 3) Following instructions when using medication (1) For external use only (Do not use internally) (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
Be careful not to 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 or sickness may occur 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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

• instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease
• instant hand antiseptic to decrease bacteria on the skin

Directions

• Pour a small amount into hands, spread evenly and rub into the skin

Other Information

- read the directions and warnings before use
- avoid freezing and excessive heat above 40 degree C (104 degree F)

Package Label : Gio Solution Sanitizer Gel 100mL

Image of carton

Package Label : Gio Solution Sanitizer Gel 500mL

Image of bottle

Package Label : Gio Solution Sanitizer Gel 1500mL

Image of bottle

GIO SOLUTION SANITIZER 
ethanol synthetic alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76532-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
AminomethylPropanol (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76532-020-01100 mL in 1 CARTON; Type 0: Not a Combination Product05/01/2020
2NDC:76532-020-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
3NDC:76532-020-031500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - GREEN WONIL CO., LTD. (688442099)
Registrant - GREEN WONIL CO., LTD. (688442099)
Establishment
NameAddressID/FEIBusiness Operations
GREEN WONIL CO., LTD.688442099manufacture(76532-020)

Revised: 5/2020
Document Id: a97c2dba-c8f0-4c3f-bfa6-56f816361383
Set id: 1e803354-51d3-4530-95a9-36a0d587d014
Version: 1
Effective Time: 20200523
 
GREEN WONIL CO., LTD.