Hello Activated Charcoal by Accupac LLC

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]

HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate paste, dentifrice 
Accupac LLC

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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

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

labelnaturally
friendly®


hello®


epic
whitening


anticavity
fluoride toothpaste


activated
charcoal


fresh mint + coconut oil


NET WT 4.0 OZ (113 g)

HELLO ACTIVATED CHARCOAL 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 44038-0678
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorblackScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 44038-0678-11 in 1 CARTON07/01/2023
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/2023
Labeler - Accupac LLC (071609663)
Registrant - Accupac LLC (061595175)
Establishment
NameAddressID/FEIBusiness Operations
Accupac LLC061595175manufacture(44038-0678)

Revised: 9/2024
Document Id: 22550564-0898-0cce-e063-6394a90abc4b
Set id: 22550564-0897-0cce-e063-6394a90abc4b
Version: 1
Effective Time: 20240917
 
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