BURTS BEES DEEP CLEAN PLUS WHITENING- sodium fluoride paste, dentifrice

Burts Bees by

Drug Labeling and Warnings

Burts Bees by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity toothpaste

Use

helps protect against cavities

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.

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

Inactive ingredients

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

Questions?

1-855-248-5352

SPL UNCLASSIFIED SECTION

*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

BURT'S

BEES®

Deep

Clean

+ Whitening

FLUORIDE

Toothpaste

prevents cavities
protects enamel
freshens breath

ADA

Accepted

American

Dental

Association

Mountain Mint

NOT TESTED ON ANIMALS

Madewithout SLS,
artificial flavors & sweeteners

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

BURTS BEES  DEEP CLEAN PLUS WHITENING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-961
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-961-47	1 in 1 CARTON	09/30/2021
1		133 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-961-03	3 in 1 CELLO PACK	01/02/2023
2		1 in 1 CARTON
2		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/30/2021

Labeler - Procter & Gamble Manufacturing Company (004238200)