HELLO WHITENING- 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® Toothpaste Whitening

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

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

Inactive ingredients

sorbitol, purified water, hydrated silica, glycerin, xylitol, calcium carbonate, xanthan gum, flavor, titanium dioxide, cocos nucifera (coconut) oil1, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract1 and melaleuca alternifolia (tea tree) oil.1

1
certified organic

Questions?

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

Distributed by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

naturally
friendly™
hello®

ADA
Accepted
American
Dental
Association ®

naturally
whitening*
fluoride toothpaste

farm grown mint
with tea tree + coconut oil

whitens naturally
prevents cavities
strengthens enamel
mind-blowing freshness

not tested
on animals

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

NET WT 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
HELLO WHITENING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-3477
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
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:55882-3477-11 in 1 CARTON09/08/202012/30/2025
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35509/08/202012/30/2025
Labeler - Hello Products LLC (040714890)

Revised: 1/2023
Document Id: 23e3d618-3f1d-43b2-8432-112a71d5e92a
Set id: a65a1998-f524-4c56-a7d7-491fe683286d
Version: 10
Effective Time: 20230127
 
Hello Products LLC