FDA.reportPublic FDA data

Burts Bees

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2025-08-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:34:59

Label at a glance#

ProductBurts Bees Extra White Mountain Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children’s brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 yrs of age.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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, hydrated silica, flavor*, sodium
lauryl glucose carboxylate, xanthan gum, lauryl glucoside, carrageenan,
stevia rebaudiana extract, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-855-248-5352

SPL UNCLASSIFIED SECTION

*contains one of these ingredients
**Peppermint Oil and other Natural Flavor

SPL UNCLASSIFIED SECTION

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 133 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Improved Formula

BURT'S BEES

Extra

White

FLUORIDE Toothpaste

prevents cavities

removes stains

protects enamel

ADA Accepted American Dental Association

Mountain Mint

Not Tested on Animals

Made without SLS, artificial flavors & sweeteners

NET WT 4.7 OZ (133 g)

ArtworkArtwork

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-81369423-813-47, 69423-813-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL GLYCOL CARBOXYLATE8L0472VMYLIACT
CARRAGEENAN5C69YCD2YJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
LAURYL GLUCOSIDE76LN7P7UCUIACT

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
463dcadd-9590-bb8e-e063-6294a90a86ba077656dc-3fc6-f37d-e063-6294a90a10ee2025-12-18WarningsExact identifier
spl set id: 077656dc-3fc6-f37d-e063-6294a90a10ee

Reported adverse events (FAERS/openFDA)#

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