HELLO JUICY GRAPE FLUORIDE- sodium fluoride paste, dentifrice

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]

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Drug Facts

Active Ingredient

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

Purpose

Anticavity

INDICATIONS & USAGE

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, hydrated silica, purified water, glycerin, xylitol, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract1.

1 certified organic

Questions?

855-HI-HELLO (1-855-444-3556)

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Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 119 g Tube Box

naturally
friendly™

hello®

fluoride toothpaste
kids ages 2+

juicy grape
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes awesome

not tested
on animals

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

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

HELLO   JUICY GRAPE FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6112
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)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6112-1	1 in 1 BOX	03/01/2021	12/31/2024
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	03/01/2021	12/31/2024

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	MANUFACTURE(55882-6112)