BURTS BEES KIDS STRAWBERRY SPLASH- 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]

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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, flavor*, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

Questions?

1-855-248-5352

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*Natural Flavor

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DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

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)

INGREDIENTS AND APPEARANCE

BURTS BEES  KIDS STRAWBERRY SPLASH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-980
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
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)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-980-42	119 g in 1 TUBE; Type 0: Not a Combination Product	12/18/2020
2	NDC: 37000-980-47	1 in 1 CARTON	01/01/2022
2		133 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-980-18	4 in 1 CELLO PACK	12/18/2020
3		1 in 1 CARTON
3		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	12/18/2020

Labeler - Procter & Gamble Manufacturing Company (004238200)