HELLO WILD STRAWBERRY- 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

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, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract

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 Label

hello®

fluoride toothpaste
kids ages 2+

tastes awesome
works brilliantly

wild strawberry
natural flavor

NET WT 4.2OZ (119g)

INGREDIENTS AND APPEARANCE

HELLO   WILD STRAWBERRY
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6099
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)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	STRAWBERRY (Wild Strawberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6099-1	1 in 1 BOX	10/05/2018
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 55882-6099-2	28 g in 1 TUBE; Type 0: Not a Combination Product	10/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	10/05/2018

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	MANUFACTURE(55882-6099)