BURTS BEES CHARCOAL PEPPERMINT- 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, sodium cocoyl glutamate*, cocamidopropyl betaine*, flavor**, xanthan gum, carrageenan, stevia rebaudiana extract, charcoal powder

Questions?

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

BURT'S

BEES®

Charcoal

FLUORIDE

Toothpaste

Charcoal

Peppermint

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

BURTS BEES  CHARCOAL PEPPERMINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-952
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
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-952-47	1 in 1 CARTON	01/01/2020
1		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 final	part355	01/01/2020

Labeler - Procter & Gamble Manufacturing Company (004238200)