KIDS ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

Kids Anticavity fluoride by

Drug Labeling and Warnings

Kids Anticavity fluoride by is a Otc medication manufactured, distributed, or labeled by TOOTHFILM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Kids Anticavity Fluoride Toothpaste(Grape)

BEST TRAINING TOOTHPASTE

Especially developed for kids above 3 years of age

A formula without preservative, triclosan, or heavy metals.

ACTIVE INGREDIENT

Sodium Fluoride 0.265%

INACTIVE INGREDIENT

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

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

WARNINGS

.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

. 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.

KEEP OUT OF REACH OF CHILDREN

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

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

PURPOSE

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82711-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.265 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOMALTITOL (UNII: QFA026JZX2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
ERYTHRITOL (UNII: RA96B954X6)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CALCIUM LACTATE (UNII: 2URQ2N32W3)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
XYLITOL (UNII: VCQ006KQ1E)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82711-005-01	80 g in 1 TUBE; Type 0: Not a Combination Product	05/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/04/2022

Labeler - TOOTHFILM INC (656036549)

Establishment
Name	Address	ID/FEI	Business Operations
TOOTHFILM INC		656036549	manufacture(82711-005)