HELLO WHITENING- sodium monofluorophosphate paste, dentifrice

Hello Whitening by

Drug Labeling and Warnings

Hello Whitening by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC. 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, xylitol, calcium carbonate, xanthan gum, flavor, titanium dioxide, cocos nucifera (coconut) oil1, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract1 and melaleuca alternifolia (tea tree) oil.1

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 - 133 g Tube Carton

naturally
friendly™
hello®

ADA
Accepted
American
Dental
Association ®

naturally
whitening*
fluoride toothpaste

farm grown mint
with tea tree + coconut oil

whitens naturally
prevents cavities
strengthens enamel
mind-blowing freshness

not tested
on animals

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

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

HELLO WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-3477
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
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: 55882-3477-1	1 in 1 CARTON	09/08/2020	12/30/2025
1		133 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	09/08/2020	12/30/2025

Labeler - Hello Products LLC (040714890)