Hello Activated Charcoal

Manufacturer
Colgate-Palmolive Company
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:09

Label at a glance#

ProductHello Activated Charcoal
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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, cocos nucifera (coconut) oil1,rebaudioside a1, tetrasodium pyrophosphate.

1 certified organic

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 113 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN3
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-678-10Hello Activated Charcoal113 g in 1 TUBEPASTE, DENTIFRICE1133
35000-678-10Hello Activated Charcoal1 in 1 CARTONPASTE, DENTIFRICE13

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
35000-67835000-678-10

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
5a92279b-c9c1-4746-b1df-612096e76fdcdec56ca7-d187-03c5-c487-c8ff7d0bf52a2024-01-19WarningsExact identifier
spl id: 5a92279b-c9c1-4746-b1df-612096e76fdc
spl set id: dec56ca7-d187-03c5-c487-c8ff7d0bf52a

Reported adverse events (FAERS/openFDA)#

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