Burt's Bees® Extra White

SPL v6

SPL

SPL Set ID 81279e1f-6224-8114-e053-2991aa0aab08

Route

DENTAL

Published

Effective Date 2018-11-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.3 mg)

Inactive Ingredients

Cocamidopropyl Betaine Carrageenan Titanium Dioxide Xanthan Gum Water Hydrated Silica Glycerin Stevia Rebaudiana Whole Sodium Cocoyl Glutamate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-01-09

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% (0.13% w/v fluoride ion)

Inactive Ingredients

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

Principal Display Panel 133 G Tube in Carton

BURT'S

BEES®

Extra

White

FLUORIDE

Toothpaste

ADA

Accepted

American

Dental

Association

Zen

Peppermint

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% (0.13% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 133 G Tube in Carton (PRINCIPAL DISPLAY PANEL - 133 g tube in carton)

BURT'S

BEES®

Extra

White

FLUORIDE

Toothpaste

ADA

Accepted

American

Dental

Association

Zen

Peppermint

NET WT 4.7 OZ (133 g)

Advanced Ingredient Data

[{"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "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"}]

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% (0.13% w/v fluoride ion)", "Inactive ingredients": "glycerin, water, hydrated silica, sodium cocoyl glutamate*, cocamidopropyl betaine*, flavor**, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide", "PRINCIPAL DISPLAY PANEL - 133 g tube in carton": "BURT'S BEES ® Extra White FLUORIDE Toothpaste ADA Accepted American Dental Association Zen Peppermint NET WT 4.7 OZ (133 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:42.430099 · Updated: 2026-03-14T23:09:37.690586