Lab52 Kids Oral Protection by TOOTHFILM INC 82711-007

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]

LAB52 KIDS ORAL PROTECTION- 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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82711-007

Kids Oral Spray(Milk)

Specially designed for children aged 0-12 to protect teeth

Xylitol 10%、Calcium Lactate 0.05%

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

- Spray 2 to 3 bursts of Lab52 Kids Oral Spray towards children's teeth anytime and anywhere. Do not forget to use with proper teeth brushing habit to acPlease use product within 90 days of opening.

- Avoid spraying in eyes. In case of contact,rinse eyes thoroughly with water.
- Stop use and ask a doctor or pharmacist ifany allergic reaction to this product or anyof its ingredients Directions

helps protect against cavities

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

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

Prevent Plaque Buidup
Oral Care AfterNight Feeding
RebairHidden Cavities

- Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years
- Use product within 90 days of openinglnactive

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
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E)	XYLITOL	10 g  in 100 g
CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM LACTATE	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CALCIUM CATION (UNII: 2M83C4R6ZB)
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)

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	08/01/2023

Labeler - TOOTHFILM INC (656036549)

Establishment
Name	Address	ID/FEI	Business Operations
TOOTHFILM INC		656036549	manufacture(82711-007)

Revised: 11/2023

Document Id: 0ab7c7a0-e259-89ec-e063-6294a90a982d

34390-5

Set id: de8c6a1d-2b39-e075-e053-2a95a90ab999

Version: 4

Effective Time: 20231122