FDA.reportPublic FDA data

Brush Buddies TOTAL CARE ANTI-CAVITY Protection

Manufacturer
Ashtel Studios, Inc.
Effective date
2023-09-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:17

Label at a glance#

ProductBrush Buddies TOTAL CARE ANTI-CAVITY Protection
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and uses

helps protect against cavities.

Dosage and administration

• adults and children 2 years and older:  brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.  • do not swallow. • children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. • children under 2 years of age:  Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%
(0.13% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 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 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 
• do not swallow.
• children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

FRESH PEPPERMINT

ANTI-CAVITY FLUORIDE TOOTHPASTE

• FRESHENS BREATH
• STRENGTHENS TEETH WITH ACTIVE FLUORIDE

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-078Brush Buddies-078

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-078-012025-01-30C16284748780-12cef2736-88ec-d83d-e063-dadaa90ab31fBB TOTAL CARE ANTI-CAVITY FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-078-01Brush Buddies TOTAL CARE ANTI-CAVITY Protection1 in 1 BOXPASTE, DENTIFRICE12
70108-078-01Brush Buddies TOTAL CARE ANTI-CAVITY Protection113 g in 1 TUBEPASTE, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-078BRUSH BUDDIES TOTAL CARE ANTI-CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]22 package rows20230923_1897f256-e3a3-46d5-9511-c5caa561e33a.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-07870108-078-01

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
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT

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
600168c1-11e7-403d-80dd-0f1e09bcfc1c1897f256-e3a3-46d5-9511-c5caa561e33a2023-09-22WarningsExact identifier
spl id: 600168c1-11e7-403d-80dd-0f1e09bcfc1c
spl set id: 1897f256-e3a3-46d5-9511-c5caa561e33a

Reported adverse events (FAERS/openFDA)#

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