EXCEED TOTAL CARE SENSITIVE SPEARMINT TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice 
Melaleuca, Inc

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.

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Exceed Total Care Sensitive Tooth Polish

Uses

Warnings

Directions

Inactive Ingredients water, hydrated silica, glycerin, sorbitol, flavor, xanthan gum, stevia leaf extract, propanediol, poloxamer 407, zinc citrate, tetrasocium pyrophosphate, titanium dioxide, lauramidopropyl betaine, benzyl alcohol, sodium hydroxide, melaleuca alternifolia (tea tree) leaf oil.

Active Ingredient Purpose

Sodium fluoride (0.243%w/w)........................Anticavity

Potassium nitrate (5.0%w/w)...................Antisensitivity

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

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EXCEED TOTAL CARE SENSITIVE  SPEARMINT TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-337
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE0.2272 g  in 93.5 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE4.675 g  in 93.5 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPANEDIOL (UNII: 5965N8W85T)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
SORBITOL (UNII: 506T60A25R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-337-0493.5 g in 1 TUBE; Type 0: Not a Combination Product01/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/08/2022
Labeler - Melaleuca, Inc (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc805617610manufacture(54473-337)

Revised: 4/2022
Document Id: dc620d3f-8810-df05-e053-2995a90a8409
Set id: dc620d3f-880f-df05-e053-2995a90a8409
Version: 1
Effective Time: 20220411
 
Melaleuca, Inc