THE KEEPS ETHANOL 62 PERCENT- 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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ACTIVE INGREDIENT

ALCOHOL 62% v/v

INACTIVE INGREDIENTS

WATER, GLYCERIN, TRIETHANOLAMINE, CARBOMER, CITRUS LIMON (LEMON) FRUIT OIL, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CHAMAECYPARIS OBTUSA OIL, DISODIUM EDTA

PURPOSE

ANTISEPTIC

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

•Hand Sanitizers
•instant hand antiseptic to decrease bacteria on the skin.

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
• Supervise children in the use of this product.

Other information

• Keep away from direct sunlight, ultra-high temperature, and ultra-low temperature
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

THE KEEPS ETHANOL 62 PERCENT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74710-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CITRUS X LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74710-0010-21 in 1 CARTON07/01/2020
1NDC:74710-0010-1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2020
Labeler - THE GUNG CO LTD (688293532)
Registrant - THE GUNG CO LTD (688293532)
Establishment
NameAddressID/FEIBusiness Operations
Woorilife&Health694860803manufacture(74710-0010)

Revised: 7/2020
Document Id: a2537bc0-b52c-4d48-ba78-088471e74f4b
Set id: 2b92673c-2d44-40d4-9e1e-2c306ad4e45a
Version: 1
Effective Time: 20200707
 
THE GUNG CO LTD