FDA.reportPublic FDA data

Kids Kare

Manufacturer
DEN-MAT HOLDINGS, LLC. | Dental Technologies Inc
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:22

Label at a glance#

ProductKids Kare
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor. Children under 2 years of age: Consult a dentist or doctor. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6. Instruct children under 6 years of age in good brushing and rinsing habits. Supervise children as necessary until ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

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 of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
  • Children under 2 years of age: Consult a dentist or doctor.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6.
  • Instruct children under 6 years of age in good brushing and rinsing habits.
  • Supervise children as necessary until capable of using without supervision.

Other information

OTHER SAFETY INFORMATION

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-752-2564

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kids kare™

Preventative

Treatment

0.24% Sodium Fluoride

Toothpaste

Berry Flavor

IMPORTANT:

Read directions carefully

Net Wt. 4 oz. (113.4 g)

Kids_Kare_ToothpasteKids_Kare_Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-718-04Kids Kare113.4 g in 1 TUBEPASTE, DENTIFRICE113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-718KIDS KARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.]3Current NDC, Legacy NDC, 1 package rows20250102_66d6b20f-d0ff-4dfe-e053-2991aa0a99ca.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
59883-71859883-718-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
SORBITOL506T60A25RIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
BERRYFV3431923ZIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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 KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
ndc (package): 59883-718-04
ndc (product): 59883-718
ndc11 (package): 59883071804
spl id: 2a9ae6d7-048d-3bd5-e063-6394a90a651e
spl set id: 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca

Reported adverse events (FAERS/openFDA)#

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