FDA.reportPublic FDA data

Lab52 Anti-Sensitivity Oral Care

Manufacturer
TOOTHFILM INC
Effective date
2022-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:01:45

Label at a glance#

ProductLab52 Anti-Sensitivity Oral Care
Active ingredientCALCIUM LACTATE, XYLITOL, POTASSIUM CITRATE
Label structure9 sections

Storage and handling

Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Potassium Citrate 5.4 %、Calcium Lactate 0.2%、Xylitol 10%

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Isomaltitol, Polysorbate 80, Lemon Flavor, Trehalose, Allantoin, Arginine, Aspalathus Linearis Extract, Sodium Bicarbonate, Ethyl Menthane Carboxamide, Sucralose, Glycyrrhiza Glabra (Licorice) Root Extract, Silica, Dicalcium Phosphate, Calcium Oxide

DOSAGE & ADMINISTRATION SECTION

When you have sensitive teeth, spray 3 times on the sensitive area to help relieve the sensitivity

WARNINGS SECTION

If you feel uncomfortable after using the product, please stop using it immediately and consult a professional doctor for assistance

INDICATIONS & USAGE SECTION

When teeth are sensitive and sore, spray 3 times on the sore area

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

Relieve tooth sensitivity and soreness, tooth protection

STORAGE AND HANDLING SECTION

Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti-Sensitivity Oral SprayAnti-Sensitivity Oral Spray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82711-002-012023-09-26C16284748780-10191ceaa-6c5b-198a-e063-dbdaa90aec3ede6312fd-1a5c-ba2a-e053-2a95a90ae0c2
82711-002-012023-07-28C16284748780-10191ceaa-6c5b-198a-e063-dbdaa90aec3ede6312fd-1a5c-ba2a-e053-2a95a90ae0c2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82711-00282711-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
LIME (CALCIUM OXIDE)C7X2M0VVNHIACT
TREHALOSEB8WCK70T7IIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM LACTATE2URQ2N32W3ACTIB
XYLITOLVCQ006KQ1EACTIB
POTASSIUM CITRATEEE90ONI6FFACTIB
ISOMALTITOLQFA026JZX2IACT
ALLANTOIN344S277G0ZIACT
ARGININE94ZLA3W45FIACT

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
063f15ef-2075-678e-e063-6394a90a73dede6312fd-1a5c-ba2a-e053-2a95a90ae0c22023-09-26WarningsExact identifier
spl set id: de6312fd-1a5c-ba2a-e053-2a95a90ae0c2

Reported adverse events (FAERS/openFDA)#

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