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Whitening Tooth Polish by Melaleuca, Inc.

Medically reviewed on February 8, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.26244g in 108g
Labeler: Melaleuca, Inc.
NDC Code: 54473-188

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.

Fluoride Tooth Polish Cool Mint Content of Label

Active ingredient
Sodium Fluoride (0.243%)

Purpose
Anticavity

Use aids in the prevention of dental 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. Warning: This product contains propolis, which can cause allergic reactions.

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 physician
  • instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol


WHITENING  TOOTH POLISH
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-188
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.26244 g  in 108 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ASCORBYL PALMITATE 
GREEN TEA LEAF 
MYRRH OIL 
GLYCERIN 
HYDRATED SILICA 
TEA TREE OIL 
PAPAIN 
POLOXAMER 407 
ACESULFAME POTASSIUM 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
SORBITOL 
POTASSIUM PYROPHOSPHATE 
SODIUM PYROPHOSPHATE 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
WATER 
XANTHAN GUM 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54473-188-04108 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

 
Melaleuca, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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