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Plak smacker great white shark cool berry flavor anti cavity fluoride gel tooth - Medication Information

Product NDC Code 70766-012
Drug Name

Plak smacker great white shark cool berry flavor anti cavity fluoride gel tooth

Type Brand
Active Ingredients
Sodium fluoride .1 g/100g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 416783
Application Number M005
Labeler Name Yangzhou SION Commodity Co.,Ltd
Packages
Package NDC Code Description
70766-012-01 144 tube in 1 box (70766-012-01) / 24 g in 1 tube
70766-012-02 5 box in 1 carton (70766-012-02) / 24 tube in 1 box / 28 g in 1 tube
70766-012-03 144 tube in 1 box (70766-012-03) / 50 g in 1 tube
70766-012-04 72 tube in 1 box (70766-012-04) / 100 g in 1 tube
70766-012-05 144 tube in 1 box (70766-012-05) / 100 g in 1 tube
70766-012-06 480 tube in 1 box (70766-012-06) / 28 g in 1 tube
70766-012-07 72 tube in 1 box (70766-012-07) / 120 g in 1 tube
70766-012-08 144 tube in 1 box (70766-012-08) / 120 g in 1 tube
70766-012-09 12 tube in 1 box (70766-012-09) / 119 g in 1 tube
70766-012-10 72 box in 1 carton (70766-012-10) / 12 tube in 1 box / 119 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients SODIUM FLUORIDE 0.24% (0.10 w/v Fluoride ion) <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text> Purpose Anti-cavity toothpaste

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENT Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium saccharin, Sodium benzoate, Trisodium phosphate, CI 42090

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Aids in the prevention of cavities.

Purpose

Information about the drug product’s indications for use.
Purpose Anti-cavity toothpaste

Spl product data elements

Usually a list of ingredients in a drug product.
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE WATER SORBITOL HYDRATED SILICA SODIUM LAURYL SULFATE XANTHAN GUM TRISODIUM PHOSPHIDE SODIUM BENZOATE XYLITOL FD&C BLUE NO. 1 SACCHARIN SODIUM SODIUM FLUORIDE FLUORIDE ION

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API