MedPath

Burts Bees

Burt's Bees Kids Strawberry Splash

Approved
Approval ID

b6c180ae-00da-6fab-e053-2a95a90a089e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37000-980
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (9)

CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STEVIA REBAUDIANA WHOLEInactive
Code: 6U422Y08O2
Classification: IACT
SODIUM COCOYL GLUTAMATEInactive
Code: BMT4RCZ3HG
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/18/2020

PRINCIPAL DISPLAY PANEL - 119 g tube

burt's

bees®

KIDS

FLUORIDE

toothpaste

STRARBERRY SPLASH

FIGHTS CAVITIES
Tastes Great
Dye Free

NET WT 4.2 OZ (119 g)

980

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/4/2013

Use

helps protect against cavities

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/13/2018

Questions?

1-855-248-5352

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/18/2020

Inactive ingredients

glycerin, water, hydrated silica, sodium cocoyl glutamate, flavor*, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

WARNINGS SECTION

LOINC: 34071-1Updated: 2/4/2013

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/14/2017

Directions

  • 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/13/2018

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/13/2018

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/4/2013

Purpose

Anticavity toothpaste

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