FDA.reportPublic FDA data

Brisa

Manufacturer
Haney, Inc.
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:16

Label at a glance#

ProductBrisa Awaken Refreshed
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-888-654-6409

SPL UNCLASSIFIED SECTION

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

116g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

brisa™

TOOTHPASTE

flouride toothpaste

Awaken Refreshed

NET WT 4.1OZ (116g) 943943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73378-002-412021-01-29C16284748780-1ba0f9c33-14df-a910-e053-dadaa90a0b85Brisa Awaken Refreshed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73378-002-41BrisaAwaken Refreshed1 in 1 CARTONPASTE, DENTIFRICE11
73378-002-41BrisaAwaken Refreshed116 g in 1 TUBEPASTE, DENTIFRICE1161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73378-002BRISA AWAKEN REFRESHED (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANEY, INC.]1Legacy NDC, 2 package rows20191021_946c8b37-7d85-4c5b-e053-2995a90ac8ed.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73378-00273378-002-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
POLYSORBATE 806OZP39ZG8HIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
FD&C BLUE NO. 1H3R47K3TBDIACT
MICAV8A1AW0880IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
946c7619-787d-2cd8-e053-2a95a90a5dea946c8b37-7d85-4c5b-e053-2995a90ac8ed2019-10-07Exact identifier
spl id: 946c7619-787d-2cd8-e053-2a95a90a5dea
spl set id: 946c8b37-7d85-4c5b-e053-2995a90ac8ed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.