Drugplain

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth .1 g/100g

SODIUM FLUORIDE · PASTE, DENTIFRICE · Yangzhou ONE & ONLY Personal Care Products Co., LTD

No Recall HistoryCurrently in Shortage
Plain English

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth is a paste, dentifrice containing sodium fluoride at .1 g/100g, taken dental. Manufactured by Yangzhou ONE & ONLY Personal Care Products Co., LTD.

Key Facts

Brand Name
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Generic Name
SODIUM FLUORIDE
NDC Code (Product)
85162-003
Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co., LTD
Strength
.1 g/100g
Dosage Form
PASTE, DENTIFRICE
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
01/16/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Aids in the prevention of cavities.

Dosage & Administration

Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician Do not swallow To minimize wallowing, use a pea sizes amount in children under 6 years Supervise children's brushing until good habits are established Children under 2 years of age: consult a dentist or physician

Warnings

Warnings Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately. Do not use if the inner foil is torn, cut, or missing Keep out of reach of children.

Frequently Asked Questions

What is Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth used for?

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth contains SODIUM FLUORIDE. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.

Is Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth a controlled substance?

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth is not classified as a controlled substance by the DEA.

What is the generic name for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth?

The generic name for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth is SODIUM FLUORIDE. There are 11 other brand versions of SODIUM FLUORIDE.

What is the NDC code for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth .1 g/100g?

The NDC (National Drug Code) for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth .1 g/100g is 85162-003, listed by Yangzhou ONE & ONLY Personal Care Products Co., LTD.