KIDS ORAL CARE VANILLA FLAVOR- xylitol, calcium lactate spray 
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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Kids Oral Care Vanilla Flavor

Active ingredients: Xylitol 2.0mL/20mL; Calcium Lactate 0.02mL/20mL

Inactive ingredients: Water, Glycerin, Sodium Levulinate, Sodium Anisate, Trehalose, Sodium Chloride, Dicalcium Phosphate, Silica, Calcium Oxide

Purpose: Anticavity

keep out of reach of children: For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.

Spray after meals and feedings. Don’t forget to brush kid's teeth for the best results! It’s fluoride-free, preservative-free, and safe to swallow when used as directed!

Apply the spray on the kiddo's teeth surface to form a protective coating. • Do not spit the spray out. • Do not rinse with water after spray. This spray is not intend to replace brushing or flossing.

Warnings: Avoid spraying in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor or pharmacist if you have an allergic reaction to this product or any of its ingredients.

Helps protect against cavities. Spray 2 to 3 times towards children's teeth to prevent plaque build up and cavities.

Question: support@lab52.com

Other: Store at 20°C to 25°C (68°F to 77°F) Use product within 90 days of opening.

Kids Oral Spray Strawberry FlavorSee Label

KIDS ORAL CARE VANILLA FLAVOR 
xylitol, calcium lactate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82711-103
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE0.02 mg  in 20 mg
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL2 mg  in 20 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM ANISATE (UNII: F9WFJ28MV9)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CALCIUM OXIDE (UNII: C7X2M0VVNH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SILICA (UNII: ETJ7Z6XBU4)  
DICALCIUM PHOSPHATE (UNII: L11K75P92J)  
TREHALOSE (UNII: B8WCK70T7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82711-103-021 in 1 BOX03/13/2025
1NDC:82711-103-0120 mg in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/13/2025
Labeler - TOOTHFILM INC. (656036549)
Establishment
NameAddressID/FEIBusiness Operations
JUN DA BEAUTY-TEC CO., LTD.658442561manufacture(82711-103) , label(82711-103)

Revised: 3/2025
Document Id: 308681fd-4c9d-8bbb-e063-6294a90a25e4
Set id: 308681e3-7b84-7c0e-e063-6394a90a4239
Version: 1
Effective Time: 20250313
 
TOOTHFILM INC.