BURTS BEES ENAMEL CARE- sodium fluoride paste, dentifrice 
Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Burt's Bees® Enamel Care

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

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

*contains one of these ingredients
**Peppermint Oil and other Natural Flavor

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 133 g tube in carton

BURT'S

BEES®

ENAMEL

CARE

FLUORIDE

Toothpaste

Mountain

Mint

NET WT 4.7 OZ (133 g)

922

BURTS BEES  ENAMEL CARE
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-922
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-922-471 in 1 CARTON10/24/2018
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-922-851 in 1 CARTON01/08/2019
224 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/24/2018
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 2/2021
Document Id: bb26155a-2ada-97bd-e053-2a95a90a29d4
Set id: 7a90471c-72b5-6560-e053-2a91aa0a6e43
Version: 3
Effective Time: 20210212
 
Procter & Gamble Manufacturing Company