Kids Anticavity fluoride

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

Label at a glance#

ProductKids Anticavity fluoride
Active ingredientSODIUM FLUORIDE
Label structure10 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#

Kids Anticavity Fluoride Toothpaste(Grape)

DESCRIPTION SECTION

BEST TRAINING TOOTHPASTE

Especially developed for kids above 3 years of age

A formula without preservative, triclosan, or heavy metals.

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.265%

INACTIVE INGREDIENT SECTION

Glycerin, Water, Silica, Xylitol, Sorbitol, Polysorbate 80, Isomaltitol, Calcium Carbonate, Grape Flavor, Erythritol, Cellulose Gum, Calcium Lactate, Potassium Acesulfame, Dicalcium Phosphate, Calcium Oxide

DOSAGE & ADMINISTRATION SECTION

. Squeeze an appropriate amount of toothpaste.Brush teeth thoroughlyafter meals or at least twice a day or use as directed by a dentist.

WARNINGS SECTION

.To minimize swallowing, use a pea-sized amount for kids under 6 years old.Once you get signs of physical discomfort, stop using the product and ask physicians for medical help.

INDICATIONS & USAGE SECTION

. Squeeze an appropriate amount of toothpaste.Brush teeth thoroughlyafter meals or at least twice a day or use as directed by a dentist.
. With proper teeth brushing habits, it helps to remove dental plaque.

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

Restore enamel
Exclusive MesoFill technology accelerates enamel restorage & strengthens teeth.
Anticavity
Sufficient sodium fluoride (800 ppm F ) to protect teeth from decay.

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

80g80g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82711-005-012023-09-26C16284748780-10191ceaa-6a3e-198a-e063-dbdaa90aec3ede8a47a5-2ac0-fa13-e053-2a95a90ab4f1
82711-005-012023-07-28C16284748780-10191ceaa-6a3e-198a-e063-dbdaa90aec3ede8a47a5-2ac0-fa13-e053-2a95a90ab4f1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82711-00582711-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
063f02ba-3f08-f2f7-e063-6394a90a7c8dde8a47a5-2ac0-fa13-e053-2a95a90ab4f12023-09-26WarningsExact identifier
spl set id: de8a47a5-2ac0-fa13-e053-2a95a90ab4f1

Reported adverse events (FAERS/openFDA)#

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