SENSITIVE 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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Sensitive Fluoride Tooth Polish

Active ingredients
Potassium nitrate (5.0% w/w)
Sodium fluoride (0.243% w/w)

Purpose
Antisensitivity
Anticavity

Uses

Warnings
When using this product do not use longer than four weeks unless recommended by a dentist

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

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

Directions

Other information

This product contains papain, which may cause allergic reactions

Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate

image of label
SENSITIVE  TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.26244 g  in 108 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5.4 g  in 108 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MYRRH OIL (UNII: H74221J5J4)  
PAPAIN (UNII: A236A06Y32)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SORBITOL (UNII: 506T60A25R)  
TEA TREE OIL (UNII: VIF565UC2G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-302-04108 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/03/2012
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.805617610manufacture(54473-302)

Revised: 3/2018
Document Id: 68933f55-0cd9-0074-e053-2991aa0adfb7
Set id: 689349e4-3980-a0e4-e053-2991aa0a9ef5
Version: 1
Effective Time: 20180329
 
Melaleuca, Inc.