HELLO  NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice 
HELLO  ACTIVATED CHARCOAL- sodium monofluorophosphate 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 monofluorophosphate 0.76% (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.

Directions

Inactive ingredients

sorbitol, purified water, hydrated silica, glycerin, xylitol, charcoal powder, flavor, xanthan gum, titanium dioxide, coconut oil, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract

Questions?

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

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 133 g Tube Label

hello®

naturally
whitening*
fluoride toothpaste

farm grown mint
with tea tree + coconut oil

NET WT4.7 OZ (133g)

Principal Display Panel - 133 g Tube Label

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

hello®

activated charcoal
with fresh mint + coconut oil

epic whitening
fluoride toothpaste

NET WT 4.0 OZ (113g)

Principal Display Panel - 113 g Tube Label
HELLO   NATURALLY WHITENING
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6100-11 in 1 BOX10/05/201810/31/2024
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:55882-6100-228 g in 1 TUBE; Type 0: Not a Combination Product10/05/201810/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/05/201810/31/2024
HELLO   ACTIVATED CHARCOAL
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6101
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorBLACKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6101-11 in 1 BOX10/05/201803/10/2023
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:55882-6101-228 g in 1 TUBE; Type 0: Not a Combination Product10/05/201803/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/05/201803/10/2023
Labeler - Hello Products LLC (040714890)

Revised: 2/2022
Document Id: eeae6d56-7360-4a60-9f7d-f2f7fb1598c9
Set id: d8ccd386-1294-4c85-9187-4efd6db47baf
Version: 4
Effective Time: 20220208
 
Hello Products LLC