HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate paste, dentifrice

Hello Activated Charcoal by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Monofluorophoshate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children 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, cocs nucifera (coconut) oil*, rebaudioside a*, tetrasodium pyrophosphate.

*certified organic

Questions?

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

Dist. by Hello Product LLC Montclair, NJ 07042

SPL UNCLASSIFIED SECTION

naturally
friendly®

hello®

epic
whitening

anticavity
fluoride toothpaste

activated
charcoal

fresh mint + coconut oil

NET WT 4.0 OZ (113 g)

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)

INGREDIENTS AND APPEARANCE

HELLO ACTIVATED CHARCOAL 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0678
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
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
COCONUT OIL (UNII: Q9L0O73W7L)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
REBAUDIOSIDE A (UNII: B3FUD0528F)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SORBITOL (UNII: 506T60A25R)
ERYTHRITOL (UNII: RA96B954X6)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0678-1	1 in 1 CARTON	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 Drug	M021	07/01/2023

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0678)