koala pals berrylicious

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.2592g in 108g
Labeler: Melaleuca, Inc.
NDC Code: 54473-204

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

KP Fluoride Tooth Gel Content of Label

Active ingredient
Sodium Fluoride 0.24% (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 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 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

KOALA PALS  BERRYLICIOUS
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-204
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.2592 g  in 108 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
GLYCERIN 
HYDRATED SILICA 
POTASSIUM SORBATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
SODIUM LAUROYL SARCOSINATE 
SORBITOL 
WATER 
XANTHAN GUM 
XYLITOL 
Packaging
#Item CodePackage Description
1NDC:54473-204-04108 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2010
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc._Knoxville805617610manufacture

Revised: 02/2011
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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