Bubble Gum Flavor For Kids 25g 50g

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2025-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:13

Label at a glance#

ProductBubble Gum Flavor For Kids 25g 50g
Active ingredientSODIUM FLUORIDE
Label structure12 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 2years Ask a dentist or physician

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.25%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Use helps protect against cavities

Warnings

WARNINGS 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.

Do not use

OTC - DO NOT USE SECTION

Do not apply on open skin wounds

OTC - WHEN USING SECTION

In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Minimize swallowing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 physician
Children 2 to 6 years
Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2years
Ask a dentist or physician

Other information

STORAGE AND HANDLING 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients 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.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-001-01Bubble Gum Flavor For Kids 25g 50g25 g in 1 TUBEOINTMENT251
85215-001-02Bubble Gum Flavor For Kids 25g 50g50 g in 1 TUBEOINTMENT501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85215-001BUBBLE GUM FLAVOR FOR KIDS 25G 50G (BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G) OINTMENT [WORLD DENTISTS ASSOCIATION AMERICA LIMITED]1Current NDC, 2 package rows20250521_354c1eda-ec5b-a8c7-e063-6294a90a871d.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
85215-00185215-001-01, 85215-001-02

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
Bubble Gum Flavor For Kids 25g 50gBUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50GWORLD DENTISTS ASSOCIATION AMERICA LIMITED354c1eda-ec5b-a8c7-e063-6294a90a871d2025-05-16WarningsExact identifier
ndc (package): 85215-001-02
ndc (package): 85215-001-01
ndc (product): 85215-001
ndc11 (package): 85215000102
ndc11 (package): 85215000101
spl id: 354c0e4d-45af-b189-e063-6394a90a96e9
spl set id: 354c1eda-ec5b-a8c7-e063-6294a90a871d

Reported adverse events (FAERS/openFDA)#

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