Lab52 Kids Oral Protection by TOOTHFILM INC 82711-006

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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82711-006

Kids Oral Spray (Strawberry)

Specially designed for children aged 0-12 to protect teeth

Xylitol 10%、Calcium Lactate 0.05%

Water, Glycerin, Sodium Levulinate, Sodium Anisate, Erythritol, Strawberry Flavor, Polysorbate 80, Silica, Dicalcium Phosphate, 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 achieve the best result. Please 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

Strawberry

LAB52 KIDS ORAL PROTECTION 
xylitol, calcium lactate aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82711-006
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE0.05 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
ERYTHRITOL (UNII: RA96B954X6)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82711-006-0120 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/04/202208/01/2023
Labeler - TOOTHFILM INC (656036549)
Establishment
NameAddressID/FEIBusiness Operations
TOOTHFILM INC656036549manufacture(82711-006)

Revised: 11/2023
 

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