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
4
Source
full-release
Hydrated at
2026-06-01 00:50:22

Label at a glance#

Productkids kare
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the get to your teeth and brush thoroghly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as ne...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

OTC - WHEN USING SECTION

When using this productit may produce surface staining of the teeth, Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
  • Apply the get to your teeth and brush thoroghly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

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

inactive ingredient

INACTIVE INGREDIENT SECTION

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or comments?

OTC - QUESTIONS SECTION

1-800-752-2564

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kids kare™

Preventative Treatment

0.4% Stannous Fluoride

Brush-On Gel

BERRY FLAVOR

IMPORTANT:

Read directions carefully

Net Wt. 4.3 oz. (121.9 g)

Kids Kare stannous gelKids Kare stannous gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-404-04kids kare121.9 g in 1 TUBEGEL121.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-404KIDS KARE (STANNOUS FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC.]4Current NDC, Legacy NDC, 1 package rows20250102_66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-40459883-404-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
BERRYFV3431923ZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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 kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
ndc (package): 59883-404-04
ndc (product): 59883-404
ndc11 (package): 59883040404
spl id: 2a998081-6425-8228-e063-6294a90adc3d
spl set id: 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91

Reported adverse events (FAERS/openFDA)#

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