Lubas by LUBASBIO CO., LTD / EQ Maxon Corp Drug Facts

Lubas by

Drug Labeling and Warnings

Lubas by is a Otc medication manufactured, distributed, or labeled by LUBASBIO CO., LTD , EQ Maxon Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUBAS- silicon dioxide paste, dentifrice 
LUBASBIO CO., LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

ACTIVE INGREDIENT

silicon dioxide


INACTIVE INGREDIENT

r-aminocapric acid, aluminium chloro hydroxy allantoinate, zeolite, polyedhylene glycol 1500, d-sorbitol solution, glycerine, erythritol, steviol giucoside, xylitol, licorice extract, lactic acid bacteria, sodium carboxymethyl cellulose, methyl parahydroxy benzoate, hydroxylapatite, sodium lauryl sulfate, coolmint flavor, mint flavor, l-menthol, dl-menthol, dionized water


PURPOSE

for dental care


KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children


INDICATIONS & USAGE

apply 1 to 3 times with desired amount of product onto teeth per day

WARNINGS

do not swallow


DOSAGE & ADMINISTRATION

for dental use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label
LUBAS 
silicon dioxide paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61165-1001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61165-1001-1120 g in 1 TUBE; Type 0: Not a Combination Product11/23/201311/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/23/201311/01/2019
Labeler - LUBASBIO CO., LTD (688734097)
Registrant - LUBASBIO CO., LTD (688734097)
Establishment
NameAddressID/FEIBusiness Operations
EQMAXON Corp.557821534manufacture(61165-1001)

Revised: 12/2019
Document Id: e31d3296-05ed-48e1-bb0c-7d7fad66efac
Set id: 3fb552ae-2077-4656-9799-279822716db3
Version: 2
Effective Time: 20191226
 
LUBASBIO CO., LTD