85215-001

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2026-10-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-22 02:01:41

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

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Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130612461002440GTIN-13: 0612461002440
EAN-13: 0612461002440
GTIN-12: 612461002440
UPC-A: 612461002440
GTIN storage (14 digits): 00612461002440
label1.jpg
BarcodeEAN-130612461261076GTIN-13: 0612461261076
EAN-13: 0612461261076
GTIN-12: 612461261076
UPC-A: 612461261076
GTIN storage (14 digits): 00612461261076
label.jpg

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-05-16full-release2026-06-01 01:01:13

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 set id: 354c1eda-ec5b-a8c7-e063-6294a90a871d

Reported adverse events (FAERS/openFDA)#

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