Burt's Bees Kids Strawberry Splash

SPL v4

SPL

SPL Set ID 087b3434-2636-74ce-e063-6394a90a25ad

Route

DENTAL

Published

Effective Date 2020-12-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.3 mg)

Inactive Ingredients

Sodium Lauryl Glycol Carboxylate Carrageenan Titanium Dioxide Xanthan Gum Water Hydrated Silica Glycerin Stevia Rebaudiana Whole Sodium Cocoyl Glutamate Lauryl Glucoside

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Drug Facts

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

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

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

Questions?

1-855-248-5352

Active Ingredient

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, water, hydrated

silica, flavor*, sodium lauryl glucose carboxylate,

xanthan gum, lauryl glucoside, carrageenan, stevia

rebaudiana extract, titanium dioxide

Principal Display Panel 119 G Tube

IMPROVED FORMULA

burt's

bees®

KIDS

fluoride

toothpaste

STRARBERRY

SPLASH

PREVENTS CAVITIES

TASTES GREAT

DYE-FREE

ADA

Accepted

American

Dental

Association

NOT TESTED ON ANIMALS

NET WT 4.7 OZ (133 g)

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity toothpaste

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

Questions?

1-855-248-5352

Active Ingredient (Active ingredient)

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, water, hydrated

silica, flavor*, sodium lauryl glucose carboxylate,

xanthan gum, lauryl glucoside, carrageenan, stevia

rebaudiana extract, titanium dioxide

Principal Display Panel 119 G Tube (PRINCIPAL DISPLAY PANEL - 119 g tube)

IMPROVED FORMULA

burt's

bees®

KIDS

fluoride

toothpaste

STRARBERRY

SPLASH

PREVENTS CAVITIES

TASTES GREAT

DYE-FREE

ADA

Accepted

American

Dental

Association

NOT TESTED ON ANIMALS

NET WT 4.7 OZ (133 g)

Advanced Ingredient Data

[{"name": "SODIUM LAURYL GLYCOL CARBOXYLATE", "unii": "8L0472VMYL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARRAGEENAN", "unii": "5C69YCD2YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIANA WHOLE", "unii": "6U422Y08O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM COCOYL GLUTAMATE", "unii": "BMT4RCZ3HG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LAURYL GLUCOSIDE", "unii": "76LN7P7UCU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Drug Facts", "50565-1": "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.", "Purpose": "Anticavity toothpaste", "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", "Questions?": "1-855-248-5352", "Active ingredient": "Sodium fluoride 0.243% (0.14% w/v fluoride ion)", "Inactive ingredients": "glycerin, water, hydrated silica, flavor*, sodium lauryl glucose carboxylate, xanthan gum, lauryl glucoside, carrageenan, stevia rebaudiana extract, titanium dioxide", "PRINCIPAL DISPLAY PANEL - 119 g tube": "IMPROVED FORMULA burt's bees ® KIDS fluoride toothpaste STRARBERRY SPLASH PREVENTS CAVITIES TASTES GREAT DYE-FREE ADA Accepted American Dental Association NOT TESTED ON ANIMALS NET WT 4.7 OZ (133 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:42.358202 · Updated: 2026-03-14T23:09:37.690586