HELLO 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® Toothpaste Charcoal

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, charcoal powder, flavor, xanthan gum, titanium dioxide, cocos nucifera (coconut) oil1, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract1

1
certified organic

Questions?

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

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

naturally
friendly™
hello®

activated charcoal
with fresh mint + coconut oil

epic whitening
fluoride toothpaste

noticeably whiter teeth
prevents cavities
safe for enamel
awesome fresh breath

never tested
on animals

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

NET WT 4.0 OZ (113g)

Principal Display Panel - 113 g Tube Carton
HELLO CHARCOAL 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-3455
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)  
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
ColorBLACK (black) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-3455-11 in 1 CARTON09/10/202012/30/2024
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 FINALpart35509/10/202012/30/2024
Labeler - Hello Products LLC (040714890)
Registrant - Colgate-Palmolive Company (001344381)

Revised: 1/2023
Document Id: bbdc4b76-0889-43cf-904b-796840d36cd9
Set id: 9d95a548-ac11-4a51-8d8f-088a367d5bab
Version: 8
Effective Time: 20230127
 
Hello Products LLC