Colgate Junior Kids Batman Mild Bubble Fruit Fluoride

Manufacturer
Mission Hills S.A de C.V
Effective date
2018-07-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:05

Label at a glance#

ProductColgate Junior Kids Batman Mild Bubble Fruit Fluoride
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, hydrated silica, PEG-12, cellulose gum, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

ADA
ACCEPTED
American
Dental
Association ®

Toothpaste

NET WT
4.6 OZ
(130 g)

Mild BUBBLE FRUIT®

PRINCIPAL DISPLAY PANEL - 130 g Tube Label
PRINCIPAL DISPLAY PANEL - 130 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
65954-585-46Colgate Junior Kids Batman Mild Bubble Fruit Fluoride130 g in 1 TUBEGEL, DENTIFRICE1304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-585COLGATE JUNIOR KIDS BATMAN MILD BUBBLE FRUIT FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4Legacy NDC, 1 package rows20241219_01eaf26d-46c7-4692-bd07-21a52ce72011.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-58565954-585-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
5435ab28-249c-4b78-bbe3-597c9965541f01eaf26d-46c7-4692-bd07-21a52ce720112018-07-02WarningsExact identifier
spl id: 5435ab28-249c-4b78-bbe3-597c9965541f
spl set id: 01eaf26d-46c7-4692-bd07-21a52ce72011

Reported adverse events (FAERS/openFDA)#

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