HELLO CBD FLUORIDE- sodium monofluorophosphate paste, dentifrice

Hello CBD Fluoride by

Drug Labeling and Warnings

Hello CBD Fluoride by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, Accupac. 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, purified water, hydrated silica, glycerin, aloe vera gel, xylitol, calcium carbonate, xanthan gum, flavor, titanium dioxide, cocos nucifera (coconut) oil, salix alba (white willow) bark extract, cocamidopropyl betaine, sodium cocoyl glutamate, cannabis sativa (hemp) flower, leaf, stem extract in caprylic/capric triglyceride (MCT oil), stevia rebaudiana leaf extract and melaleuca alternifolia (tea tree) oil

Questions?

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

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Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

naturally
friendly™
hello®

cbd
fluoride
toothpaste

cannabis sativa oil
+ tea tree oil

natural fresh mint flavor

whitens naturally
prevents cavities
safe for enamel
freshens breath

broad spectrum hemp oil
grown in the usa

NET WT 3.0 OZ (85g)

INGREDIENTS AND APPEARANCE

HELLO CBD FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6106
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
Salix Alba Bark (UNII: 205MXS71H7)
CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)

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: 55882-6106-1	1 in 1 BOX	01/28/2020
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 55882-6106-2	1 in 1 CARTON	01/28/2020
2		85 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	01/28/2020

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	MANUFACTURE(55882-6106)