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®

Drug Facts

Active Ingredient

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

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.

Twist off cap to remove foil seal.

Do not use if 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 years of age: Use a pea-sized amount and supervise until good brushing habits are established to minimize swallowing.
  • Children under 2 years of age: Consult a dentist or physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Purified Water, Xylitol, Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide and Stevia Rebaudiana Leaf Extract.

Questions?

855-HI-HELLO (1-855-444-3556)

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 142 g Tube Box - Peach Mango Mint

hello®

fluoride toothpaste

prevents cavities, strengthens enamel,
polishes teeth + freshens breath

peach mango mint

NET WT 5OZ (142g)

Principal Display Panel - 142 g Tube Box - Peach Mango Mint

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Bubble Gum

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

bubble gum

NET WT 4.2OZ (119g)

Principal Display Panel - 119 g Tube Box - Bubble Gum

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Green Apple

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

green apple

NET WT 4.2OZ (119g)

Principal Display Panel - 119 g Tube Box - Green Apple

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Blue Raspberry

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

blue raspberry

NET WT 4.2OZ (119g)

Principal Display Panel - 119 g Tube Box - Blue Raspberry
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6092
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
FlavorPEACH, MANGO, MINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6092-11 in 1 BOX03/01/201503/03/2023
1142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/201503/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6093
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
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6093-11 in 1 BOX03/01/201503/03/2023
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/201503/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6094
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
FlavorAPPLE (Green Apple) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6094-11 in 1 BOX03/01/201503/03/2023
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/201503/03/2023
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6095
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
FlavorRASPBERRY (Blue Raspberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6095-11 in 1 BOX03/01/201503/03/2023
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/201503/03/2023
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(55882-6092, 55882-6093, 55882-6094, 55882-6095)

Revised: 3/2015
Document Id: 7bb2a1ef-e478-4ed8-890f-11432e9a91b2
Set id: 5e4197ed-2ed5-41cc-817e-8e9213dc780a
Version: 3
Effective Time: 20150320
 
Hello Products LLC