Hello Unicor Sparkle by Accupac LLC

Hello Unicor Sparkle by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO UNICOR SPARKLE- sodium fluoride gel, dentifrice 
Accupac LLC

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Hello Unicorn Sparkle

Drug Facts

Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

help 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 thoroghly, preferably after each meal or at least twice a day, or as directed by a dentist of 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 of physician.

Inactive ingredients

sorbitol, purified water, hydrated silica, glycerin, xylitol, xanthan gum, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract, mica, 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)

HELLO UNICOR SPARKLE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0686
Route of Administration	DENTAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0686-1	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(44038-0686)

Revised: 10/2024

Document Id: 236ae750-bb8a-6114-e063-6394a90aa28f

34390-5

Set id: 236ae750-bb89-6114-e063-6394a90aa28f

Version: 1

Effective Time: 20241001