Hello® Dragon Dazzle Fluoride

Hello by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO  DRAGON DAZZLE FLUORIDE- 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®
Dragon Dazzle Fluoride

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 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 Carton

naturally
friendly
hello®

dragon dazzle
fluoride toothpaste
kids ages 2+

blue raspberry
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

never tested
on dragons

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

NET WT 4.2 OZ (119 g)

HELLO   DRAGON DAZZLE FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6116
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6116-1	1 in 1 CARTON	06/01/2021	07/01/2023
1		119 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	06/01/2021	07/01/2023

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	MANUFACTURE(55882-6116)

Revised: 7/2023

Document Id: f8638c97-a4e4-4ee0-9078-fa73267f34ea

34390-5

Set id: b01a640d-7dfb-4ba5-b27b-b294b4e47b5c

Version: 2

Effective Time: 20230701