Kids Prime Pediatric Dental Group Anticavity for Kids

Manufacturer
Prime Tooth Care LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:34

Label at a glance#

ProductKids Prime Pediatric Dental Group Anticavity for Kids
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

 Adults and children 2 years of age and older  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.  Children 2 to 6 years  Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)  Children under 2 years  Ask a dentist or physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.25%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children 2 to 6 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 Children under 2 years Ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

Other information

SPL UNCLASSIFIED SECTION

Store in a cool place, below 86°F, away from heat
Do not use if quality seal is broken or missing
Do not use after the expiration date

Package Labeling: 25g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Package Labeling: 50g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130612461002440GTIN-13: 0612461002440
EAN-13: 0612461002440
GTIN-12: 612461002440
UPC-A: 612461002440
GTIN storage (14 digits): 00612461002440
Label02.jpg
BarcodeEAN-130612461261076GTIN-13: 0612461261076
EAN-13: 0612461261076
GTIN-12: 612461261076
UPC-A: 612461261076
GTIN storage (14 digits): 00612461261076
Label0.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87053-008-00Kids Prime Pediatric Dental Group Anticavity for Kids25 g in 1 TUBEOINTMENT252
87053-008-00Kids Prime Pediatric Dental Group Anticavity for Kids1 in 1 BOXOINTMENT12
87053-008-01Kids Prime Pediatric Dental Group Anticavity for Kids1 in 1 BOXOINTMENT12
87053-008-01Kids Prime Pediatric Dental Group Anticavity for Kids50 g in 1 TUBEOINTMENT502

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
87053-00887053-008-00, 87053-008-01

Ingredients#

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

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

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
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
ndc (package): 87053-008-00
ndc (package): 87053-008-01
ndc (product): 87053-008
ndc11 (package): 87053000800
ndc11 (package): 87053000801
spl id: 47f528ed-bb97-37ef-e063-6394a90a6bc0
spl set id: 93259174-447d-4f7a-8e55-990eb8da5151

Reported adverse events (FAERS/openFDA)#

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