COLGATE KIDS WATERMELON FLAVOR

Manufacturer
Colgate-Palmolive Company
Effective date
2019-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:24

Label at a glance#

ProductCOLGATE KIDS WATERMELON FLAVOR
Active ingredientSODIUM FLUORIDE
Label structure10 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 physician 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

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 of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, flavor, xanthan gum, FD&C blue no. 1, FD&C yellow no. 5

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 in 1
Toothpaste
& Mouthwash

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity and Enamel Protection

WATERMELON FLAVOR

NET WT 4.6 OZ (130 g) LIQUID GEL

Principal Display Panel - 130 g Bottle Label
Principal Display Panel - 130 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-905-81COLGATE KIDS WATERMELON FLAVOR130 g in 1 BOTTLEGEL, DENTIFRICE1302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-905COLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Legacy NDC, 1 package rows20241020_14bb69a3-438c-4af8-8ac5-ccc361b9e3a7.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-90535000-905-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
b2a7591f-b48b-4a03-a91b-9215d7f83b9814bb69a3-438c-4af8-8ac5-ccc361b9e3a72019-12-02WarningsExact identifier
spl id: b2a7591f-b48b-4a03-a91b-9215d7f83b98
spl set id: 14bb69a3-438c-4af8-8ac5-ccc361b9e3a7

Reported adverse events (FAERS/openFDA)#

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