Kids Anticavity fluoride by TOOTHFILM INC Marketing End 005

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- sodium fluoride paste, dentifrice 
TOOTHFILM INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Marketing End 005

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.

Sodium Fluoride 0.265%

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

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

.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.

. 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.

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

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

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

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

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	05/01/2023

Labeler - TOOTHFILM INC (656036549)

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

Revised: 9/2023

Document Id: 063f02ba-3f08-f2f7-e063-6394a90a7c8d

34390-5

Set id: de8a47a5-2ac0-fa13-e053-2a95a90ab4f1

Version: 2

Effective Time: 20230926