FDA.reportPublic FDA data

Kids Oral Care Flavor Free

Manufacturer
TOOTHFILM INC. | JUN DA BEAUTY-TEC CO., LTD.
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:25

Label at a glance#

ProductKids Oral Care Flavor Free
Active ingredientCALCIUM LACTATE, XYLITOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

OTC - QUESTIONS SECTION

Question: support@lab52.com

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kids Oral Care Flavor FreeKids Oral Care Flavor FreeSee Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82711-106-01Kids Oral Care Flavor Free20 mg in 1 BOTTLESPRAY201
82711-106-02Kids Oral Care Flavor Free1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82711-106KIDS ORAL CARE FLAVOR FREE (XYLITOL, CALCIUM LACTATE) SPRAY [TOOTHFILM INC.]1Current NDC, 2 package rows20250422_33469d77-4013-413d-e063-6294a90acbb7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82711-10682711-106-01, 82711-106-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ANISATEF9WFJ28MV9IACT
SODIUM LEVULINATEVK44E1MQU8IACT
SODIUM CHLORIDE451W47IQ8XIACT
CALCIUM OXIDEC7X2M0VVNHIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SILICAETJ7Z6XBU4IACT
DICALCIUM PHOSPHATEL11K75P92JIACT
TREHALOSEB8WCK70T7IIACT
CALCIUM LACTATE2URQ2N32W3ACTIB
XYLITOLVCQ006KQ1EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Oral Care Flavor FreeXYLITOL, CALCIUM LACTATETOOTHFILM INC.33469d77-4013-413d-e063-6294a90acbb72025-04-21WarningsExact identifier
ndc (package): 82711-106-01
ndc (package): 82711-106-02
ndc (product): 82711-106
ndc11 (package): 82711010601
ndc11 (package): 82711010602
spl id: 3346a27c-3d4d-48a8-e063-6394a90a0ba7
spl set id: 33469d77-4013-413d-e063-6294a90acbb7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.