The Humble Co. Fresh Mint Strawberry Flavour

Manufacturer
The Humble Company North America, Inc
Effective date
2020-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:59:39

Label at a glance#

ProductThe Humble Co. Fresh Mint Strawberry Flavour
Active ingredientSODIUM FLUORIDE
Label structure8 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 doctor. Children under 6 years of age Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

WARNINGS SECTION

Keep out of reach of children under 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 olderBrush teeth thoroughly, preferably  after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of ageInstruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of ageConsult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

store below 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, lauryl glucoside, xanthan gum, flavor, zinc gluconate, titanium dioxide, peppermint oil, mica, stevia rebaudiana extract, spearmint leaf oil, iron oxides, limonene

Questions?

OTC - QUESTIONS SECTION

Call 1(858) 876-5174

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72299-01572299-015-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
d3ae7e3a-71d7-c247-e053-2a95a90ad70cb79fef7e-4715-9f04-e053-2995a90aa9352021-12-21WarningsExact identifier
spl set id: b79fef7e-4715-9f04-e053-2995a90aa935

Reported adverse events (FAERS/openFDA)#

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