Kolorz
FDA Label NDC 10733-372

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medical Products Laboratories, Inc. for the product Kolorz (NDC 10733-372). 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 dosage & administration, warnings, precautions, how supplied, indications & usage, 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

Dosage & Administration

Dosage and Administration
Shake can vigorously before each use. Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. Dry tooth surface and insert tray(s) in mouth. Have patient bite down lightly but firmly for 1 to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

Instructions For Use
The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser.

CONTAINS
Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.

Warnings

WARNING Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach children. Store between 55-80 F. Keep from freezing.

Precautions

CAUTIONFor professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Shake well before each use.

How Supplied

How Supplied
Kolorz Sixty Second Fluoride Foam is available in 4.4 oz. (125g) can and do not contain chlorofluorocarbon propellant.

Indications & Usage

INDICATIONS
For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

Image Of Package Insert (Insert)

Image Of Package Insert (Insert)

Package Label.Principal Display Panel

kolorz Sixty Second Fluoride Foam Blue Raspberry

Image Of Can Label (Kolorz)

Image Of Can Label (Kolorz)

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