Lab52 Anti-Sensitivity Oral Care by TOOTHFILM INC Marketing End 002

Lab52 Anti-Sensitivity Oral Care by

Drug Labeling and Warnings

Lab52 Anti-Sensitivity Oral Care by is a Otc medication manufactured, distributed, or labeled by TOOTHFILM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAB52 ANTI-SENSITIVITY ORAL CARE- xylitol, calcium lactate, potassium citrate aerosol 
TOOTHFILM INC

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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Marketing End 002

Potassium Citrate 5.4 %、Calcium Lactate 0.2%、Xylitol 10%

Water, Glycerin, Propylene Glycol, Isomaltitol, Polysorbate 80, Lemon Flavor, Trehalose, Allantoin, Arginine, Aspalathus Linearis Extract, Sodium Bicarbonate, Ethyl Menthane Carboxamide, Sucralose, Glycyrrhiza Glabra (Licorice) Root Extract, Silica, Dicalcium Phosphate, Calcium Oxide

When you have sensitive teeth, spray 3 times on the sensitive area to help relieve the sensitivity

If you feel uncomfortable after using the product, please stop using it immediately and consult a professional doctor for assistance

When teeth are sensitive and sore, spray 3 times on the sore area

Please keep out of reach of children under 6 years old.

Children under six years of age must be supervised by an adult

Relieve tooth sensitivity and soreness, tooth protection

Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years

Anti-Sensitivity Oral Spray

LAB52 ANTI-SENSITIVITY ORAL CARE 
xylitol, calcium lactate, potassium citrate aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82711-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE0.2 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL10 g  in 100 g
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE5.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
TREHALOSE (UNII: B8WCK70T7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ARGININE (UNII: 94ZLA3W45F)  
ISOMALTITOL (UNII: QFA026JZX2)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82711-002-0115 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/07/202205/01/2023
Labeler - TOOTHFILM INC (656036549)
Establishment
NameAddressID/FEIBusiness Operations
TOOTHFILM INC656036549manufacture(82711-002)

Revised: 9/2023
 

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