Burts Bees For Kids (Sodium Fluoride) Paste, Dentifrice [Procter & Gamble Manufacturing Company] -

BURTS BEES FOR KIDS (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC	37000-924-42
Set ID	7a92a749-f007-31f2-e053-2a91aa0a711a
Category	HUMAN OTC DRUG LABEL
Packager	Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number	PART355

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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, titanium dioxide
Questions?

1-855-248-5352
SPL UNCLASSIFIED SECTION

**Natural Flavor

*contains one of these ingredients
SPL UNCLASSIFIED SECTION

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202
PRINCIPAL DISPLAY PANEL - 119 g tube

BURT'S

BEES®

for Kids

FLUORIDE

Toothpaste

Fruit Fusion

flavor

We Don't Add What You Don't Want†
Prevents Cavities
Tastes Great
Dye Free

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

BURTS BEES FOR KIDS
sodium fluoride paste, dentifrice

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

Ingredient Name	Strength
Inactive Ingredients
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)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-924-42	119 g in 1 TUBE; Type 0: Not a Combination Product	10/24/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/24/2018

Labeler - Procter & Gamble Manufacturing Company (004238200)

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Medic