BURTS BEES KIDS STRAWBERRY SPLASH- sodium fluoride paste, dentifrice

Burts Bees Kids by

Drug Labeling and Warnings

Burts Bees Kids 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% (0.14% 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, flavor*, sodium lauryl glucose carboxylate,
xanthan gum, lauryl glucoside, 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

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)

INGREDIENTS AND APPEARANCE

BURTS BEES KIDS  STRAWBERRY SPLASH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-819
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
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
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)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-819-47	133 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/01/2023

Labeler - Procter & Gamble Manufacturing Company (004238200)