DR. LIBEAUTE HAND SANITIZER- alcohol gel 
Ongoong 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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Drug Facts

ethyl alcohol

Water, Glycerin, carbomer, triethanolamine, tocopheryl acetate, pinis koralensis seed extract, camellia sinensis seed extract, aloe barbadensis left extract, melaleuca alternifolia (tea tree) leaf oil menthol, peppermint oil, butylene glycol, 1,2-hexanediol

Antiseptic

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

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

KEEP OUT OF REACH OF THE CHILDREN

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.

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

for external use only

label

DR. LIBEAUTE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74084-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74084-0009-13785 mL in 1 CONTAINER; Type 0: Not a Combination Product05/16/2020
2NDC:74084-0009-2300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/16/2020
Labeler - Ongoong Co Ltd (695625965)
Registrant - Ongoong Co Ltd (695625965)
Establishment
NameAddressID/FEIBusiness Operations
Ongoong Co Ltd695625965label(74084-0009) , manufacture(74084-0009)

Revised: 5/2020
Document Id: a5c041cc-858c-7379-e053-2a95a90a5477
Set id: a5bfe781-c206-688f-e053-2995a90a948c
Version: 1
Effective Time: 20200516
 
Ongoong Co Ltd