Hello® Bye Bye Bacteria Fluoride Toothpaste

Hello by

Drug Labeling and Warnings

Hello by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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)

HELLO   BYE BYE BACTERIA FLUORIDE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6117
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6117-1	1 in 1 CARTON	01/03/2022	06/30/2024
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/03/2022	06/30/2024

Labeler - Hello Products LLC (040714890)

Revised: 3/2023

Document Id: a7e671ab-0da1-4b51-b86c-fee15df53b1d

34390-5

Set id: b8048981-e8a1-4ce5-a74c-bb60dff77276

Version: 3

Effective Time: 20230313