HELLO DRAGON DAZZLE- sodium fluoride paste, dentifrice

Hello Dragon Dazzle by

Drug Labeling and Warnings

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

Drug Details [pdf]

Hello Dragon Dazzle

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 a 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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

HELLO DRAGON DAZZLE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0679
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
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
MICA (UNII: V8A1AW0880)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SORBITOL (UNII: 506T60A25R)

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: 44038-0679-1	1 in 1 CARTON	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 Drug	M021	07/01/2023

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0679)