Hello Unicorn by Hello Products LLC Hello® Unicorn

Drug Details [pdf]

HELLO UNICORN- sodium fluoride gel, 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® Unicorn

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)

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

naturally
friendly
hello®

unicorn sparkle
fluoride toothpaste
kids ages 2+

bubble gum
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

never tested
on unicorns

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

NET WT 4.2 OZ (119g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

HELLO UNICORN
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-3488
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55882-3488-1	1 in 1 CARTON	02/20/2021	07/01/2023
1		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	02/20/2021	07/01/2023

Labeler - Hello Products LLC (040714890)

Revised: 7/2023

Document Id: d6f6d652-6372-47c7-84e4-ec46324d19f4

Set id: 723520d1-6d14-ee9c-518d-2eef513c53d7

Version: 6

Effective Time: 20230701