77 DISINFECTION ETHANOL LIQUI D- alcohol spray 
SUNGSUBIOTEK 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 83% v/v

INACTIVE INGREDIENT

Water

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• disinfection of hard object surfaces

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

• Store between 59-86℉ (15-30℃)
• Avoid freezing and excessive heat above 104℉ (40℃)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

77 DISINFECTION ETHANOL LIQUI D 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80454-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol415 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80454-010-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - SUNGSUBIOTEK CO. LTD. (690452683)
Registrant - SUNGSUBIOTEK CO. LTD. (690452683)
Establishment
NameAddressID/FEIBusiness Operations
SUNGSUBIOTEK CO. LTD.690452683manufacture(80454-010)

Revised: 9/2020
Document Id: d9e492dc-68e5-4858-8f3d-7b9b03886094
Set id: 0f6b3d59-63b1-4a67-b875-9b2a24368922
Version: 1
Effective Time: 20200911
 
SUNGSUBIOTEK CO. LTD.