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

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

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
  • children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
  • children under 2 years: ask a dentist or a physician.

Inactive ingredients

sorbitol, purified water, hydrated silica, glycerin, xylitol, xanthan gum, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract, mica and titanium dioxide.

Questions?

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

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 119 g Tube Box

naturally
friendly™
hello®

unicorn sparkle
fluoride toothpaste
kids ages 2+

bubble gum
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

never tested
on unicorns

no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.

NET WT 4.2 OZ (119g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Box
HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6107
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)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
MICA (UNII: V8A1AW0880)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6107-11 in 1 BOX08/01/202004/30/2023
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/01/202004/30/2023
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663MANUFACTURE(55882-6107)

Revised: 1/2022
Document Id: 80a53212-e10e-44f7-b063-5ed4bca73858
Set id: 424cb024-3f21-45de-8ed1-81458759902f
Version: 3
Effective Time: 20220119
 
Hello Products LLC