FDA.reportPublic FDA data

Brush Buddies SENSITIVE Extra Whitening

Manufacturer
Ashtel Studios, Inc.
Effective date
2023-09-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:18

Label at a glance#

ProductBrush Buddies SENSITIVE Extra Whitening
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities.

Dosage and administration

• adults and children 12 years & older:  • apply at least a 1-inch strip of the product onto a soft bristle toothbrush  • brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. • children under 12 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%
Sodium Fluoride 0.24% (0.15 % w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity
Anticavity

Uses

INDICATIONS & USAGE SECTION

• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 years 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 12 years & older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush 
• brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Make sure to brush all sensitive areas of the teeth.
• minimize swallowing. Spit out after brushing.
• children under 12 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Treated Water, PEG-1500, Sodium Lauryl Sulphate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

FRESH MINT

• FRESHENS BREATH
• STRENGTHENS TEETH WITH ACTIVE FLUORIDE

Compares to the active ingredients in Sensodyne® Extra Whitening*

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Sensodyne®.

DESIGNED IN U.S.A.  •  MADE IN INDIA

Brush Buddies®
WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN USA
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brush Buddies-079Brush Buddies-079

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-079-012025-01-30C16284748780-12cef2736-746d-d83d-e063-dadaa90ab31fBB SENSITIVE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-079-01Brush Buddies SENSITIVE Extra Whitening1 in 1 BOXPASTE, DENTIFRICE12
70108-079-01Brush Buddies SENSITIVE Extra Whitening113 g in 1 TUBEPASTE, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-079BRUSH BUDDIES SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]22 package rows20230927_8cf604dd-a7e4-474a-b7c7-dde469b91a50.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-07970108-079-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
cfaf57e8-0123-44b9-8eb7-ef9518d06fbe8cf604dd-a7e4-474a-b7c7-dde469b91a502023-09-26WarningsExact identifier
spl id: cfaf57e8-0123-44b9-8eb7-ef9518d06fbe
spl set id: 8cf604dd-a7e4-474a-b7c7-dde469b91a50

Reported adverse events (FAERS/openFDA)#

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