LAB52 ANTI-CAVITY ORAL CARE- xylitol, calcium lactate aerosol

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]

ACTIVE INGREDIENT

Xylitol 12%、Calcium Lactate 0.05%

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

WARNINGS

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

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

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

PURPOSE

Oral cleaning, tooth protection, powerful deodorization

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)
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)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
TREHALOSE (UNII: B8WCK70T7I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Labeler - TOOTHFILM INC (656036549)

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