FDA.reportPublic FDA data

Shopkins Brush Buddies

Manufacturer
Ashtel Studios Inc.
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:38

Label at a glance#

ProductShopkins Brush Buddies
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Sodium Fluoride 0.243% (0.15% w/v fluoride ion) ......................... Anticavity

INDICATIONS & USAGE SECTION

Helps protect teeth and roots against cavities

WARNINGS SECTION

keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Blue #1, FD &C Red # 40

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
To minimize swallowing use a pea-sized amount in children under 6 years of age.
Supervise children's brushing until good habits are established.
Children under 2 years of age: Ask a dentist.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-005-012024-01-30C16284748780-11030e365-3017-111a-e063-dadaa90a10e2Shopkins Brush Buddies

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-005-01Shopkins Brush Buddies119 g in 1 TUBEPASTE1192

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-005SHOPKINS BRUSH BUDDIES (SODIUM FLUORIDE) PASTE [ASHTEL STUDIOS INC.]2Legacy NDC, 1 package rows20200101_383a884e-78ce-27ee-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-00570108-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEB70850QPHRIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SORBITOL506T60A25RIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
WATER059QF0KO0RIACT
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOLS8TT5K3C8YIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
9d2bbd2d-7f91-45a4-887a-7fe82fa1a4ac383a884e-78ce-27ee-e054-00144ff8d46c2019-12-31WarningsExact identifier
spl id: 9d2bbd2d-7f91-45a4-887a-7fe82fa1a4ac
spl set id: 383a884e-78ce-27ee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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