Quorum Bio CO.,LTD - LuBi AMPOULE

LuBi AMPOULE by

Drug Labeling and Warnings

LuBi AMPOULE by is a Otc medication manufactured, distributed, or labeled by Quorum Bio CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUBI AMPOULE- adenosine, niacinamide, glycerin gel 
Quorum Bio 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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Quorum Bio CO.,LTD - LuBi AMPOULE

ACTIVE INGREDIENT

Niacinamide 2%, Adenosine 0.04%, Glycerin 1%

INACTIVE INGREDIENT

Aspergillus/Rice Ferment Extract, Butylene Glycol, 1,2-Hexanediol, Sodium Hyaluronate, Chlorphenesin, Ethylhexylglycerin, Polyglyceryl-10 Laurate, Polyglyceryl-4 Laurate, Caprylyl/Capryl Glucoside, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water

PURPOSE

Skin care.

Wrinkle, dry skin and dark spot care.

WARNINGS

For external use only.

Do not use when skin is red, inflamed, irritated, or painful

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS AND USAGE

Apply 2 or 3 drops after cleansing. Massage gently until it is absorbed.

DOSAGE AND ADMINISTRATION

For external use only.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

label

LUBI AMPOULE 
adenosine, niacinamide, glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70635-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 100 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70635-0005-150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/11/201912/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34712/11/201912/23/2019
Labeler - Quorum Bio CO.,LTD (695798936)
Registrant - Quorum Bio CO.,LTD (695798936)
Establishment
NameAddressID/FEIBusiness Operations
Quorum Bio CO.,LTD695798936manufacture(70635-0005)

Revised: 12/2019
Document Id: 9a5ad09a-2b0b-6798-e053-2a95a90a9804
Set id: 99797bb1-ff45-0cda-e053-2995a90a2aae
Version: 2
Effective Time: 20191223
 
Quorum Bio CO.,LTD