HELLO ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE- sodium monofluorophosphate 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 monofluorophosphate 0.76% (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, hydrated silica, vegetable glycerin, xylitol, purified water, charcoal powder, flavor, xanthan gum, titanium dioxide, camellia sinensis (matcha) leaf extract, cocos nucifera (coconut) oil, 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 - 113 g Tube Box

naturally
friendly™
hello®

activated charcoal +
matcha green tea

farm grown mint

epic whitening
fluoride toothpaste

noticeably whiter teeth
removes plaque
prevents cavities
excites tastebuds

never tested
on animals

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

NET WT 4.0 OZ (113g)

INGREDIENTS AND APPEARANCE

HELLO   ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium monofluorophosphate (UNII: C810JCZ56Q) (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)
Activated Charcoal (UNII: 2P3VWU3H10)
Xanthan Gum (UNII: TTV12P4NEE)
Titanium dioxide (UNII: 15FIX9V2JP)
Coconut Oil (UNII: Q9L0O73W7L)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Green Tea Leaf (UNII: W2ZU1RY8B0)

Product Characteristics
Color	BLACK	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6105-1	1 in 1 BOX	12/01/2019
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	12/01/2019

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	MANUFACTURE(55882-6105)