Koala Pals Paste, Dentifrice
FDA Label NDC 54473-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Koala Pals (NDC 54473-300). 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 otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, dosage & administration, inactive ingredient, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient
Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)

Otc - Purpose

Purpose
Anticavity

Indications & Usage

Use aids in the prevention of cavities

Otc - Keep Out Of Reach Of Children

Warnings
Keep out of 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.

Dosage & Administration

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 doctor
  • children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
  • children under 2 years of age: ask a dentist or doctor

Inactive Ingredient

Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol

Warnings

Warnings

* Please review the disclaimer below.