HELLO  BYE BYE BACTERIA FLUORIDE- 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®
Bye Bye Bacteria Fluoride Toothpaste

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, calcium carbonate, erythritol, xylitol, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, cocos nucifera (coconut) oil1, sodium cocoyl glutamate, zinc citrate, rebaudioside A1, melaleuca alternifolia (tea tree) leaf oil.


1
certified organic

Questions?

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

Distributed by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

seriously
friendly
hello®

bye bye
bacteria*

fluoride toothpaste
with zinc + tea tree oil

mmm, tasty
herbal mint

*kills bad breath bacteria

NET WT 4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
HELLO   BYE BYE BACTERIA FLUORIDE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6117
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)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ERYTHRITOL (UNII: RA96B954X6)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
ZINC CITRATE (UNII: K72I3DEX9B)  
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:55882-6117-11 in 1 CARTON01/03/202206/30/2024
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 FINALpart35501/03/202206/30/2024
Labeler - Hello Products LLC (040714890)

Revised: 3/2023
Document Id: a7e671ab-0da1-4b51-b86c-fee15df53b1d
Set id: b8048981-e8a1-4ce5-a74c-bb60dff77276
Version: 3
Effective Time: 20230313
 
Hello Products LLC