(ETHANOL70%) DR KEEPS ONE GEL (ETHANOL)- alcohol gel 
THE GUNG 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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alcohol

Water, Carbomer, Triethanolamine, Glycerin, Lemon oil, aloe vera extract, greentea extract, EDTA

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

■ if following abnormal symptoms persist, discontinue use

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

(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.

■ pour a small amount into hands, spread evenly and rub into the skin

for topical use only

label

(ETHANOL70%) DR KEEPS ONE GEL (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74710-0005
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL (UNII: I9GRO824LL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74710-0005-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/04/2020
Labeler - THE GUNG CO LTD (688293532)
Registrant - THE GUNG CO LTD (688293532)
Establishment
NameAddressID/FEIBusiness Operations
THE GUNG CO LTD688293532manufacture(74710-0005)

Revised: 4/2020
Document Id: a39f4e60-64cb-58dc-e053-2995a90a98f9
Set id: a39f4d92-398f-59cd-e053-2995a90a4f49
Version: 1
Effective Time: 20200419
 
THE GUNG CO LTD