Burst Toothpaste

Burst Toothpaste
SPL v4
SPL
SPL Set ID 48c22ca2-1238-6d6e-e054-00144ff8d46c
Route
DENTAL
Published
Effective Date 2017-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 mg)
Inactive Ingredients
Benzyl Alcohol Carboxymethylcellulose Glycerin Polyethylene Glycol 1500 Propylene Glycol Triclosan Silicon Dioxide Sodium Benzoate Sodium Hydroxide Sodium Lauryl Sulfate Saccharin Sodium Sorbitol Xanthan Gum Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-02-20

Description

Sodium fluoride 0.243%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.243%

Uses

Aids in the prevention of dental cavities

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

Package Label

Active Ingredient

Sodium fluoride 0.243%

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

Keep Out of the Reach of Children

under 6 years of age.


Structured Label Content

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity

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

Package Label

Active Ingredient

Sodium fluoride 0.243%

Inactive Ingredients (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

Keep Out of the Reach of Children (Keep out of the reach of children)

under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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