Active Ingredient
Sodium Fluoride 0.24%(0.14% w/v Fluoride ion)
Plak Smacker Anti Cavity Fluoride Paste
FDA Label NDC 72326-8002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Young Ps Acquisition, Llc for the product Plak Smacker Anti Cavity Fluoride (NDC 72326-8002). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, 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
Purpose
Anticavity toothpaste
Uses
Helps aid in the prevention of dental cavities.
Warnings
Keep out of the reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Do not use if 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, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
- Do not swallow
- To minimize swallowing use a pea sized amount in children under 6
- Instruct children under 6 years of age in good brushing and rinsing habits
- Supervise children as necessary until capable of using without supervision
Inactive Ingredients
Sorbitol,Water , Hydrated silica, PEG1500, Sodium Lauryl Sulfate, Flavor , Sodium Carboxy Methyl Cellulose , Sodium Saccharin,Sodium Benzoate, Blue1, Red 33
Package Label.Principal Display Panel
Product Label 120 (120g)
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