FDA.reportPublic FDA data

AutoBrush strawberry

Manufacturer
Lander Enterprises, LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:29:44

Label at a glance#

ProductAutoBrush strawberry
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

● Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician. ● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). ● Shake before use. ● Squirt two times into your mouth and start brushing. ● Supervise children as necessary until capable of using without super...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%

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 of age and older: Brush teeth thoroughly, preferably
after each meal or at least twice per day, or as directed by a dentist or physician.
● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
● Shake before use.
● Squirt two times into your mouth and start brushing.
● Supervise children as necessary until capable of using without supervision.
● Children under 2 years of age: consult a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Strawberry Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate

● Questions?

SPL UNCLASSIFIED SECTION

● Email Support: customercare@autobrush.com
● Phone Support: 1-888-468-7404

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810101900570GTIN-13: 0810101900570
EAN-13: 0810101900570
GTIN-12: 810101900570
UPC-A: 810101900570
GTIN storage (14 digits): 00810101900570		IMAGE-2.jpg
QR code linkQR Codeqr.tryautobrush.com/g/4JSR2boczsAIMAGE-1.jpg, IMAGE-2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82913-002-01AutoBrush strawberry1 in 1 CARTONLIQUID16
82913-002-01AutoBrush strawberry50 mL in 1 BOTTLE, PLASTICLIQUID506

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82913-00282913-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
XYLITOLVCQ006KQ1EIACT
SILVER3M4G523W1GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEVIOSIDE0YON5MXJ9PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CALCIUM CITRATEMLM29U2X85IACT
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
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
ndc (package): 82913-002-01
ndc (product): 82913-002
ndc11 (package): 82913000201
spl id: 47433131-14e2-7dc8-e063-6394a90a0090
spl set id: 05929148-bffe-439f-a9d4-3170816c0fa2

Reported adverse events (FAERS/openFDA)#

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