FDA.reportPublic FDA data

Lab 52 Essential Oil Sensitive

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#

ProductLab 52 Essential Oil Sensitive
Active ingredientPOTASSIUM CITRATE, SODIUM FLUORIDE
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 5.53%，Sodium Fluoride 0.32%

INACTIVE INGREDIENT SECTION

Glycerin, Water, Silica, Sodium Lauroyl Sarcosinate, Polysorbate 80, Isomaltitol, Calcium Lactate, Eucalyptus Globulus Leaf Oil, Menthol, Cellulose Gum, Dicalcium Phosphate, Citrus Aurantium Dulcis (Orange) Oil, Potassium Acesulfame, Titanium Dioxide, Mentha Arvensis Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Allantoin, Dipotassium Glycyrrhizinate, Calcium Oxide

DOSAGE & ADMINISTRATION SECTION

Squeeze out an appropriate amount and clean your mouth with correct brushing habits, at least 2 times a day, at least 2-3 minutes each time

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

For sensitive tooth pain, protect teeth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep out of reach of children
Prohibited for use by children

OTC - PURPOSE SECTION

Reduce sensitive tooth pain

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

Essential Oil Sensitive ToothpasteEssential Oil Sensitive Toothpaste

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82711-003-012023-09-26C16284748780-10191ceaa-7281-198a-e063-dbdaa90aec3ede6485bc-35b2-539b-e053-2995a90ab28d
82711-003-012023-07-28C16284748780-10191ceaa-7281-198a-e063-dbdaa90aec3ede6485bc-35b2-539b-e053-2995a90ab28d

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82711-00382711-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHOLL7T10EIP3AIACT
ORANGE OILAKN3KSD11BIACT
POTASSIUM CITRATEEE90ONI6FFACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
CLOVE OIL578389D6D0IACT
CALCIUM LACTATE2URQ2N32W3IACT
WATER059QF0KO0RIACT
EUCALYPTUS OIL2R04ONI662IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
SPEARMINT OILC3M81465G5IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
ISOMALTITOLQFA026JZX2IACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
ALLANTOIN344S277G0ZIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
LIME (CALCIUM OXIDE)C7X2M0VVNHIACT

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
063f2eaa-b633-e73f-e063-6294a90aa075de6485bc-35b2-539b-e053-2995a90ab28d2023-09-26WarningsExact identifier
spl set id: de6485bc-35b2-539b-e053-2995a90ab28d

Reported adverse events (FAERS/openFDA)#

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