FDA.reportPublic FDA data

The Humble Co. Anticavity Mouthwash Strawberry Kids

Manufacturer
The Humble Company North America Inc
Effective date
2021-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:38:41

Label at a glance#

ProductThe Humble Co. Anticavity Mouthwash Strawberry Kids
Active ingredientSODIUM FLUORIDE
Label structure8 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 30 seconds 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities

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 30 seconds 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 cool and dry place.
  • This mouthwash is not intended to replace brushing or flossing
  • Store at 59°F to 77°F. 
  • Keep from freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, betaine, polysorbate-80, peppermint (mentha x piperita l.) oil, rebaudioside A, aloe vera (aloe barbadensis) leaf juice, citric acid, sodium benzoate, potassium sorbate

Questions?

OTC - QUESTIONS SECTION

Call (619) 940-6502

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72299-01772299-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
BETAINE3SCV180C9WIACT
POLYSORBATE 806OZP39ZG8HIACT
PEPPERMINT OILAV092KU4JHIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
071193ac-34d8-244b-e063-6294a90a9e7cc926dc3a-b466-1bc8-e053-2995a90af0782023-10-06WarningsExact identifier
spl set id: c926dc3a-b466-1bc8-e053-2995a90af078

Reported adverse events (FAERS/openFDA)#

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