FDA.reportPublic FDA data

Active Ingredient

Manufacturer
Lander Enterprises, LLC | Guangzhou Xinuo Technology Co., Ltd.
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-20 01:00:58

Label at a glance#

ProductAutoBrush Mint
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 2 years and older: Shake before use. Gently dispense one pump on each side of your toothbrush head. (If using a manual toothbrush, you can dispense two pumps directly into your mouth.) Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowin...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS 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 Central right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older:

  • Shake before use.
  • Gently dispense one pump on each side of your toothbrush head.
  • (If using a manual toothbrush, you can dispense two pumps directly into your mouth.)
  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.

Children under 2 years:

Consult a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, glycerin, poloxamer 407, sodium lauroyl sarcosinate, peg-40 hydrogenated castor oil, xylitol, cellulose gum, pepermint oil (flavor), stevia rebaudiana leaf extract, potassium sorbate, sodium benzoate, sodium bicarbonate, calcium citrate, menthol

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82913-01182913-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
XYLITOLVCQ006KQ1EIACT
CELLULOSE GUMK679OBS311IACT
STEVIA REBAUDIANA LEAF6TC6NN0876IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
CALCIUM CITRATEMLM29U2X85IACT
MENTHOLL7T10EIP3AIACT
POLOXAMER 407TUF2IVW3M2IACT

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
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
ndc (package): 82913-011-01
ndc (product): 82913-011
ndc11 (package): 82913001101
spl id: 58b244a6-0add-76d2-e063-6394a90ae091
spl set id: 0e043431-9d87-478d-87f5-5aa8b0a932eb

Reported adverse events (FAERS/openFDA)#

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