Hello Charcoal by Hello Products LLC Hello® Charcoal

Hello Charcoal by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO CHARCOAL- 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® Charcoal

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, sorbitol, xylitol, erythritol, charcoal powder, flavor, xanthan gum, sodium bicarbonate, sodium cocoyl glutamate, potassium citrate, cocamidopropyl betaine, cocos nucifera (coconut) oil1,rebaudioside a1, tetrasodium pyrophosphate.

1 certified organic

Questions?

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

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

naturally
friendly®
hello®

epic
whitening

anticavity
fluoride toothpaste

activated
charcoal

fresh mint + coconut oil

NET WT 4.0 OZ (113 g)

HELLO CHARCOAL 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6230
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)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
ERYTHRITOL (UNII: RA96B954X6)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCONUT OIL (UNII: Q9L0O73W7L)
REBAUDIOSIDE A (UNII: B3FUD0528F)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6230-1	1 in 1 CARTON	02/01/2023	07/01/2023
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	02/01/2023	07/01/2023

Labeler - Hello Products LLC (040714890)

Revised: 8/2023

Document Id: c660f094-4cb9-42cd-9e07-1820cc93625e

34390-5

Set id: 8cd8a2f3-426e-28cf-953c-30f0d0fd7a62

Version: 2

Effective Time: 20230802