BRISA TROPICAL FRESH- sodium fluoride paste, dentifrice

Brisa by

Drug Labeling and Warnings

Brisa by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, Haney, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

WARNINGS

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

SPL UNCLASSIFIED SECTION

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

116g tube in carton

brisa™

TOOTHPASTE

flouride toothpaste

Tropical Fresh

NET WT 4.1OZ (116g)

INGREDIENTS AND APPEARANCE

BRISA  TROPICAL FRESH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-442
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 37000-442-41	1 in 1 CARTON	10/21/2019
1		116 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	10/21/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
Haney, Inc.		788699445	repack(37000-442)