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

80g

KIDS ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82711-005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.265 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82711-005-0180 g in 1 TUBE; Type 0: Not a Combination Product05/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/04/202205/01/2023
Labeler - TOOTHFILM INC (656036549)
Establishment
NameAddressID/FEIBusiness Operations
TOOTHFILM INC656036549manufacture(82711-005)

Revised: 9/2023
 

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