Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth Paste, Dentifrice
FDA Label NDC 85162-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yangzhou One & Only Personal Care Products Co., Ltd for the product Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth (NDC 85162-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredient

→ Package Label.principal Display Panel

Active Ingredients

SODIUM FLUORIDE 0.24% (0.11 w/v Fluoride ion)

<text > <paragraph>SODIUM FLUORIDE 0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text > <paragraph>SODIUM FLUORIDE 0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text > &lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text > &amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text > &amp;amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/> &amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text></text>

Purpose

Anti-cavity toothpaste

Uses

Aids in the prevention of cavities.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090

Package Label.Principal Display Panel

Image Description (Label)

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