Hello® Naturally Whitening

Hello Naturally Whitening by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice 
Hello Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hello® Naturally Whitening

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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

glycerin, water, hydrated silica, calcium carbonate, sorbitol, erythritol, xylitol, flavor, xanthan gum, sodium bicarbonate, potassium citrate, sodium cocoyl glutamate, cocamidopropyl betaine, cocos nucifera (coconut) oil, rebaudioside a1, melaleuca alternifolia (tea tree) leaf oil.

1 certified organic

Questions?

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

Distributed by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

naturally
friendly®

hello®

naturally
whitening*

anticavity
fluoride toothpaste

mint
to be

farm grown mint + coconut oil
NET WT 4.7 OZ (133 g)

HELLO NATURALLY WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6250
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCONUT OIL (UNII: Q9L0O73W7L)
REBAUDIOSIDE A (UNII: B3FUD0528F)
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: 55882-6250-1	1 in 1 CARTON	01/01/2023	07/01/2023
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	01/01/2023	07/01/2023

Labeler - Hello Products LLC (040714890)

Revised: 1/2023

Document Id: 63303805-d59f-4aba-b9e2-56f8cf52f980

34390-5

Set id: d8360607-d743-a0f1-7bb0-ea1631b5a626

Version: 2

Effective Time: 20230127