BURTS BEES CLEAN AND FRESH- 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® Clean & Fresh

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

*contains one of these ingredients

**Peppermint, Eucalyptus, and Spearmint Oils and other Natural Flavor

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 133 g tube in carton

BURT'S

BEES®

Clean

& Fresh

FLUORIDE

Toothpaste

Mint

Medlet

NET WT 4.7 OZ (133 g)

923

BURTS BEES  CLEAN AND FRESH
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-923
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
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)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-923-471 in 1 CARTON10/24/201807/31/2021
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/24/201807/31/2021
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2023
Document Id: f91539a4-6bfe-7eff-e053-6394a90a1662
Set id: 7a9289d3-d8fb-c180-e053-2a91aa0a8cb7
Version: 4
Effective Time: 20230411
 
Procter & Gamble Manufacturing Company