HELLO- sodium fluoride paste, dentifrice 
Hello Products LLC

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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Hello™ Anticavity Toothpaste

Drug Facts

Active Ingredient

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

Purpose

Anticavity

Use

Helps protect against 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. Do not use if the safety seal is missing or broken.

Directions

  • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
  • Do not swallow.
  • Children under 6: Use a pea sized amount and supervise until good brushing habits are established to minimize swallowing.
  • Children under 2: Ask a dentist.

Inactive Ingredients

Sorbitol, Hydrated Silica, Vegetable Glycerin, Purified Water, Xylitol, Natural and Artificial Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide and Stevia.

Questions?

855-HI-HELLO

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - supermint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

supermint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - supermint

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - sweet cinnamint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

sweet cinnamint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - sweet cinnamint

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - mojito mint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

mojito mint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - mojito mint

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - pink grapefruit mint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

pink grapefruit mint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - pink grapefruit mint
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6011
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Supermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6011-1177 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/201303/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/04/201303/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6013
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCINNAMON (Sweet Cinnamint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6013-1177 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/201303/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/04/201303/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6012
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorLIME (Mojito Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6012-1177 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/201303/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/04/201303/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6014
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorGRAPEFRUIT (Pink Grapefruit Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6014-1177 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/201303/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/04/201303/03/2023
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(55882-6011, 55882-6013, 55882-6012, 55882-6014)

Revised: 2/2013
Document Id: a87e8ad2-f281-4d5f-a72b-82050f9fddbc
Set id: eb37ae4a-4c5f-4e25-8424-587677539d18
Version: 2
Effective Time: 20130211
 
Hello Products LLC