Lab52 Kids Oral Protection

Manufacturer
TOOTHFILM INC
Effective date
2023-09-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:25:40

Label at a glance#

ProductLab52 Kids Oral Protection
Active ingredientXYLITOL, CALCIUM LACTATE
Label structure11 sections

Storage and handling

- 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

Label contents#

Full prescribing information#

Kids Oral Spray(Milk)

DESCRIPTION SECTION

Specially designed for children aged 0-12 to protect teeth

OTC - ACTIVE INGREDIENT SECTION

Xylitol 10%、Calcium Lactate 0.05%

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

- 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.

WARNINGS SECTION

- 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

INDICATIONS & USAGE SECTION

helps protect against cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

OTC - PURPOSE SECTION

Prevent Plaque Buidup
Oral Care AfterNight Feeding
RebairHidden Cavities

STORAGE AND HANDLING SECTION

- 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

RECENT MAJOR CHANGES SECTION

1、Modified description of usage and dosage
2、Revise the purpose description to summarize the purpose in an easy-to-understand manner

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MilkMilk

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82711-007-012023-09-26C16284748780-10191ceaa-6a1b-198a-e063-dbdaa90aec3e82711-007
82711-007-012023-07-28C16284748780-10191ceaa-6a1b-198a-e063-dbdaa90aec3e82711-007

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82711-00782711-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
0ab7c7a0-e259-89ec-e063-6294a90a982dde8c6a1d-2b39-e075-e053-2a95a90ab9992023-11-22WarningsExact identifier
spl set id: de8c6a1d-2b39-e075-e053-2a95a90ab999

Reported adverse events (FAERS/openFDA)#

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