DAEYU HAND SANITIZER GEL- alcohol gel 
Dae Yu 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.

----------

79548-202

Active ingredient

Ethanol 62%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Hexyl Cinnamic Aldehyde, Linalool, Benzyl Acetate, Benzyl Benzoate, Hedione

Package Label

500ml NDC: 79548-202-01 Label

DAEYU HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79548-202
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
BENZYL BENZOATE (UNII: N863NB338G)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79548-202-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/14/2020
Labeler - Dae Yu Co., Ltd (687952549)
Registrant - Dae Yu Co., Ltd (687952549)
Establishment
NameAddressID/FEIBusiness Operations
Dae Yu Co., Ltd687952549manufacture(79548-202)

Revised: 7/2020
Document Id: aa61603b-1607-36c9-e053-2995a90ad7c9
Set id: aa61603b-1606-36c9-e053-2995a90ad7c9
Version: 1
Effective Time: 20200714
 
Dae Yu Co., Ltd