Active Ingredients
Sodium Fluoride 0.243% (equivalent to 0.13% w/v fluoride ion)
Plak Smacker
FDA Label NDC 71775-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lmz for the product Plak Smacker (NDC 71775-080). 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 ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-cavity
Uses
Aids in the prevention of cavities
Warnings
If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
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 physician.
Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.
Children under 2 years: Ask a dentist or a physician.
Inactive Ingredients
Sorbitol, Silica, Water, PEG-8, Sodium lauryl sulfate, Flavor, Titanium dioxide, Cellulose gum, Trisodium phosphate, Sodium saccharin, Xanthan gum, Benzyl alcohol, Xylitol, CI 42090
Principal Display Panel
28 g NDC: 71775-080-01
* Please review the disclaimer below.
