The Humble Co Anticavity Mouthwash Charcoal

Manufacturer
The Humble Company North America Inc
Effective date
2021-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:36:44

Label at a glance#

ProductThe Humble Co Anticavity Mouthwash Charcoal
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluride 0.05% (0.02% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental caries

Warning

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

Keep the bottle closed and store in a fresh and dry place. Do not use if carton/case is open.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, betaine, polysorbate-80, peppermint (mentha x piperita l.) oil, flavor, rebaudioside A, lycium (lycium barbarum) fruit extract, green tea (camellia sinensis) extract, asian ginseng (panax ginseng) root extract, aloe vera (aloe barbadensis) leaf juice, citric acid, charcoal powder, sodium benzoate, potassium sorbate, limonene

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72299-010-002021-09-10C16284748780-1ba0f9c33-1ffd-a910-e053-dadaa90a0b85The Humble Co Anticavity Mouthwash Charcoal
72299-010-002021-01-29C16284748780-1ba0f9c33-1ffd-a910-e053-dadaa90a0b85The Humble Co Anticavity Mouthwash Charcoal

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72299-01072299-010-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
07115890-3831-c009-e063-6294a90ac50e4d5d4236-74ef-43e7-806d-5c35d613fe942023-10-06WarningsExact identifier
spl set id: 4d5d4236-74ef-43e7-806d-5c35d613fe94

Reported adverse events (FAERS/openFDA)#

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