Label: BURST WONDERFULLY WHITENING ANTI CAVITY- sodium fluoride paste, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 71275-001-47 - Packager: BURST.USA.Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Keep out of the reach of children
- Warnings
-
Directions
adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician
- Inactive ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
BURST WONDERFULLY WHITENING ANTI CAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71275-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRICLOSAN (UNII: 4NM5039Y5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:71275-001-47 133 g in 1 TUBE; Type 0: Not a Combination Product 02/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/20/2017 Labeler - BURST.USA.Inc (080474113)