LAB52 KIDS ORAL PROTECTION- xylitol, calcium lactate aerosol

Lab52 Kids Oral Protection by

Drug Labeling and Warnings

Lab52 Kids Oral Protection by is a Otc medication manufactured, distributed, or labeled by TOOTHFILM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Kids Oral Spray(Milk)

Specially designed for children aged 0-12 to protect teeth

ACTIVE INGREDIENT

Xylitol 10%、Calcium Lactate 0.05%

INACTIVE INGREDIENT

Water, Glycerin, Sodium Levulinate, Sodium Anisate, Trehalose, Propylene Glycol, Milk Flavor, Sodium Chloride, Polysorbate 80, Milk Calcium, Dicalcium Phosphate, Silica, Calcium Oxide

DOSAGE & ADMINISTRATION

3 sprays each time to inhibit tooth decay bacteria

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

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 KIDS ORAL PROTECTION 
xylitol, calcium lactate aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82711-007
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	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ANISATE (UNII: F9WFJ28MV9)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CALCIUM CATION (UNII: 2M83C4R6ZB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82711-007-01	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(82711-007)