Hello Activated Charcoal

Manufacturer
Accupac LLC
Effective date
2024-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:54:20

Label at a glance#

ProductHello Activated Charcoal
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelnaturally
friendly®


hello®


epic
whitening


anticavity
fluoride toothpaste


activated
charcoal


fresh mint + coconut oil


NET WT 4.0 OZ (113 g)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44038-067844038-0678-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
22550564-0898-0cce-e063-6394a90abc4b22550564-0897-0cce-e063-6394a90abc4b2024-09-17WarningsExact identifier
spl id: 22550564-0898-0cce-e063-6394a90abc4b
spl set id: 22550564-0897-0cce-e063-6394a90abc4b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.