KOALA PALS FLUORIDE TOOTH GEL - sodium fluoride paste 
Melaleuca, Inc.

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Koala Pals Fluoride Tooth Gel Content of Label

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

Purpose
Anticavity

Use aids in the prevention of cavities

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.

Directions

• adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal, or at lease 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 ingredients acesulfame potassium, citric acid (naturally derived), flavor, glycerin (vegetable-derived), hydrated silica, natural lemon and orange flavor extracts, potassium sorbate (food grade), sodium benzoate (food grade), sodium bicarbonate (baking soda), sodium lauroyl sarcosinate, sorbitol (vegetable-derived), water, xanthan gum (vegetable-derived), xylitol (vegetable-derived)

KOALA PALS  FLUORIDE TOOTH GEL sodium fluoride   paste

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54473-140 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.2592 g  in 108 g

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM   ANHYDROUS CITRIC ACID   GLYCERIN   HYDRATED SILICA   POTASSIUM SORBATE   SODIUM BENZOATE   SODIUM BICARBONATE   SODIUM LAUROYL SARCOSINATE   SORBITOL   WATER   XANTHAN GUM   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor BERRY (Berrylicious) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54473-140-03 108 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/19/2008	04/01/2010

Labeler - Melaleuca, Inc. (139760102)

Revised: 02/2011Melaleuca, Inc.