Label: BURTS BEES ENAMEL CARE- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 37000-922-47, 37000-922-85 - Packager: Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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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
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 g tube in carton
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INGREDIENTS AND APPEARANCE
BURTS BEES ENAMEL CARE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-922 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 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 Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-922-47 1 in 1 CARTON 10/24/2018 1 133 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37000-922-85 1 in 1 CARTON 01/08/2019 2 24 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 final part355 10/24/2018 Labeler - Procter & Gamble Manufacturing Company (004238200)