HELLO HEMP SEED OIL PLUS COCONUT OIL EXTRA FRESHENING 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

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, purified water, glycerin, xylitol, erythritol, flavor, xanthan gum, titanium dioxide, cannabis sativa (hemp) seed oil1, cocos nucifera (coconut) oil, sodium cocoyl glutamate, cocamidopropyl betaine, stevia rebaudiana leaf extract1 and melaleuca alternifolia (tea tree) oil.

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®

hemp seed oil
+ coconut oil

natural fresh spearmint

extra freshening
fluoride toothpaste

prevents cavities
whitens naturally
moisturizes magnificently
strengthens enamel

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   HEMP SEED OIL PLUS COCONUT OIL EXTRA FRESHENING FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6104
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)
Erythritol (UNII: RA96B954X6)
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)
Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6104-1	1 in 1 BOX	10/01/2019
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	10/01/2019

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	MANUFACTURE(55882-6104)