Brisa Tropical Fresh: Package Insert and Label Information

BRISA TROPICAL FRESH- sodium fluoride paste, dentifrice
Haney, Inc.

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 Facts

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, cocos nucifera (coconut) oil, sucralose, polysorbate 80, titanium dioxide

Questions?

1-888-654-6409

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

116g tube in carton

brisa™

TOOTHPASTE

flouride toothpaste

Tropical Fresh

NET WT 4.1OZ (116g)

942

BRISA TROPICAL FRESH sodium fluoride paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73378-001 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE POLYSORBATE 80 HYDRATED SILICA TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM COCONUT OIL SORBITOL SACCHARIN SODIUM (SACCHARIN) SODIUM LAURYL SULFATE SODIUM HYDROXIDE SODIUM ACID PYROPHOSPHATE WATER SUCRALOSE

Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73378-001-41 1 TUBE in 1 CARTON contains a TUBE 1 116 g in 1 TUBE This package is contained within the CARTON (73378-001-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/21/2019

Labeler — Haney, Inc. (788699445)

Revised: 10/2019 Haney, Inc.