V34 TOOTHPASTE. TABLETS.- v34 toothpaste tablets tablet 
LLRN PERSONAL CARE(SHENZHEN)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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Active Ingredient

Sodium Bicarbonate 7%

Phthalimidoperoxycaproic Acid 6%

Hydrated Silica 5%

Purpose

Whitening, Fresh Breath, Clean mouth

Use

Place tablets in your mouth.
Chew until it foams.
Brush your teeth as usual. Use twice daily.

Warnings

Prouducts is not intended for use by children.
Do not swallow.

Do not use

Pregnant woman and children under 12 years old.

When Using

Do not swallow foams.

Stop Use

Stop use if you feel unwell or nausea.

Ask Doctor

Call a POISON CENTER or doctor/physician if you feel unwell for an extended period of time afer use.

Keep Oot Of Reach Of Children

Keep Out Of Reach Of Children

Directions

Place tablets in your mouth.
Chew until it foams.
Brush your teeth as usual. Use twice daily.

Inactive ingredients

Microcrystalline Cellulose, Maltodextrin, Mannitol, Malic Acid, Sodium Carbonate, Calcium Carbonate, Xanthan Gum, Sucralose, Magnesium Stearate, Aroma, Acid Red 33, CI 42090, Methyl Diisopropyl Propionamide

PRINCIPAL DISPLAY PANEL

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V34 TOOTHPASTE. TABLETS. 
v34 toothpaste tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83812-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID6 g  in 100 
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE7 g  in 100 
HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA5 g  in 100 
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
AROMADENDRIN (UNII: 7YA4640575)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
MALIC ACID (UNII: 817L1N4CKP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83812-005-0130 in 1 BOTTLE; Type 0: Not a Combination Product11/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/24/2023
Labeler - LLRN PERSONAL CARE(SHENZHEN)CO., LTD (419890311)
Establishment
NameAddressID/FEIBusiness Operations
LLRN PERSONAL CARE(SHENZHEN)CO., LTD419890311label(83812-005) , manufacture(83812-005)

Revised: 11/2023
Document Id: 0af2587d-07ca-285a-e063-6394a90a2ebf
Set id: 0af2587d-07c9-285a-e063-6394a90a2ebf
Version: 1
Effective Time: 20231124
 
LLRN PERSONAL CARE(SHENZHEN)CO., LTD