Lab52 Anti-Cavity Oral Care by TOOTHFILM INC

Lab52 Anti-Cavity Oral Care by

Drug Labeling and Warnings

Lab52 Anti-Cavity 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-CAVITY ORAL CARE- xylitol, calcium lactate 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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Xylitol 12%、Calcium Lactate 0.05%

Water, Glycerin, Propylene Glycol, Erythritol, Sodium Levulinate, Sodium Anisate, Polysorbate 80, Orange Flavor, Citrus Aurantium Dulcis (Orange) Oil, Aspalathus Linearis Extract, Trehalose, Sodium Bicarbonate, Ethyl Menthane Carboxamide, Mentha Arvensis(Peppermint )Leaf Oil, Silica, Calcium Oxide, Dicalcium PhosphateWater, Glycerin, Propylene Glycol, Erythritol, Sodium Levulinate, Sodium Anisate, Polysorbate 80, Orange Flavor, Citrus Aurantium Dulcis (Orange) Oil, Aspalathus Linearis Extract, Trehalose, Sodium Bicarbonate, Ethyl Menthane Carboxamide, Mentha Arvensis(Peppermint )Leaf Oil, Silica, Calcium Oxide, Dicalcium Phosphate

Use after meals, after brushing your teeth and before going to bed

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

Use after meals, after brushing your teeth and before going to bed to help protect your teeth, with correct brushing habits, the effect is better

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

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

Oral cleaning, tooth protection, powerful deodorization

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

LAB52 ANTI-CAVITY ORAL CARE 
xylitol, calcium lactate aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82711-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM LACTATE	0.05 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E)	XYLITOL	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
GLYCERIN (UNII: PDC6A3C0OX)
ERYTHRITOL (UNII: RA96B954X6)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ORANGE OIL (UNII: AKN3KSD11B)
SODIUM ANISATE (UNII: F9WFJ28MV9)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82711-001-01	20 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/04/2022	05/01/2023

Labeler - TOOTHFILM INC (656036549)

Establishment
Name	Address	ID/FEI	Business Operations
TOOTHFILM INC		656036549	manufacture(82711-001)

Revised: 9/2023

Document Id: 063e58b1-4166-41e0-e063-6394a90a2bfb

34390-5

Set id: de270f7b-2b8a-8d9e-e053-2995a90a8815

Version: 2

Effective Time: 20230926