BURST WONDERFULLY WHITENING ANTI CAVITY- sodium fluoride paste, dentifrice

BURST by

Drug Labeling and Warnings

BURST by is a Otc medication manufactured, distributed, or labeled by BURST.USA.Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.243%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Keep out of the reach of children

under 6 years of age.

Warnings

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 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

benzyl alcohol, cellulose gum, flavor, glycerin, PEG-32, propylene glycol, PVM/MA copolymer, silica, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

Package Label

INGREDIENTS AND APPEARANCE

BURST  WONDERFULLY WHITENING ANTI CAVITY
sodium fluoride paste, dentifrice

Product 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)