HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate paste, dentifrice

Hello by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, purified water, hydrated silica, glycerin, xylitol, charcoal powder, flavor, xanthan gum, titanium dioxide, coconut oil, 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 - 133 g Tube Label

hello®

naturally
whitening*
fluoride toothpaste

farm grown mint
with tea tree + coconut oil

NET WT4.7 OZ (133g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

hello®

activated charcoal
with fresh mint + coconut oil

epic whitening
fluoride toothpaste

NET WT 4.0 OZ (113g)

INGREDIENTS AND APPEARANCE

HELLO   NATURALLY WHITENING
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6100
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)
Calcium Carbonate (UNII: H0G9379FGK)
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)
Tea Tree Oil (UNII: VIF565UC2G)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6100-1	1 in 1 BOX	10/05/2018
1		133 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 55882-6100-2	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

HELLO   ACTIVATED CHARCOAL
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6101
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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6101-1	1 in 1 BOX	10/05/2018
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 55882-6101-2	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(55882-6100, 55882-6101)