FDA.reportPublic FDA data

Burts Bees

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:05

Label at a glance#

ProductBurts Bees Enamel care
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, sodium cocoyl glutamate*, cocamidopropyl betaine*, flavor**, xanthan gum, 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

BURT'S

BEES®

ENAMEL

CARE

FLUORIDE

Toothpaste

Mountain

Mint

NET WT 4.7 OZ (133 g)

922922

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-922-472023-01-30C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care
37000-922-852023-01-30C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care
37000-922-472021-02-12C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care
37000-922-852021-02-12C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care
37000-922-472021-01-29C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care
37000-922-852021-01-29C16284748780-1ba0f9c33-42e1-a910-e053-dadaa90a0b85Burt's Bees® Enamel Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-922-47Burts BeesEnamel care1 in 1 CARTONPASTE, DENTIFRICE13
37000-922-47Burts BeesEnamel care133 g in 1 TUBEPASTE, DENTIFRICE1333
37000-922-85Burts BeesEnamel care24 g in 1 TUBEPASTE, DENTIFRICE243
37000-922-85Burts BeesEnamel care1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-922BURTS BEES ENAMEL CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3Legacy NDC, 4 package rows20210213_7a90471c-72b5-6560-e053-2a91aa0a6e43.zip

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
37000-92237000-922-47, 37000-922-85

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
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CARRAGEENAN5C69YCD2YJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT

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
bb26155a-2ada-97bd-e053-2a95a90a29d47a90471c-72b5-6560-e053-2a91aa0a6e432021-02-12WarningsExact identifier
spl id: bb26155a-2ada-97bd-e053-2a95a90a29d4
spl set id: 7a90471c-72b5-6560-e053-2a91aa0a6e43

Reported adverse events (FAERS/openFDA)#

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