Burts Bees

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2026-02-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:36:33

Label at a glance#

ProductBurts Bees Charcoal Peppermint
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, charcoal powder

Questions?

OTC - QUESTIONS SECTION

1-855-248-5352

SPL UNCLASSIFIED SECTION

*contains one of these ingredients

**Peppermint, Eucalyptus, and Spearmint Oils 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®

Charcoal

+Whitening

FLUORIDE

Toothpaste

Mountain Mint

Made without Parabens, SLS, and Artificial Flavors

NET WT 4.7 OZ (133 g)

965965

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN9
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD9
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-965-03Burts BeesCharcoal Peppermint1 in 1 CARTONPASTE, DENTIFRICE19
37000-965-03Burts BeesCharcoal Peppermint3 in 1 CELLO PACKPASTE, DENTIFRICE39
37000-965-47Burts BeesCharcoal Peppermint133 g in 1 TUBEPASTE, DENTIFRICE1339
37000-965-47Burts BeesCharcoal Peppermint1 in 1 CARTONPASTE, DENTIFRICE19

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
37000-96537000-965-47, 37000-965-03

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-01-08monthly-update2026-06-03 17:51:48
72025-06-13full-release2026-06-01 01:03:04

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
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
ndc (package): 37000-965-47
ndc (package): 37000-965-03
ndc (product): 37000-965
ndc11 (package): 37000096503
ndc11 (package): 37000096547
spl id: 49dcbf6e-591b-f627-e063-6394a90ae90a
spl set id: a343853e-4968-2753-e053-2995a90ab152

Reported adverse events (FAERS/openFDA)#

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