85215-002

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2025-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:13

Label at a glance#

ProductFluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blue...
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

Directions ■Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at east twice a day, or use as directed by a dentist or doctor. ■Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). ■Supervise children as necessary until capable of using without supervision. ■Children under 2 years of age: Consult a dentist or doctor.

Storage and handling

Store in a cool and shady place

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.25% (100PPM)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Use helps protect against cavities

Warnings

WARNINGS SECTION

When using this product

Do not swallow

Do not use in eye area

Do not use

OTC - DO NOT USE SECTION

Do not use in eye area

OTC - WHEN USING SECTION

When using this product

Do not swallow

OTC - STOP USE SECTION

When using this product keep out of eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Teach 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

Directions ■Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after
each meal or at east twice a day, or use as directed by a dentist or doctor.

■Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
■Supervise children as necessary until capable of using without supervision.

■Children under 2 years of age: Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

Store in a cool and shady place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroy| Sarcosinate, Fragrancel Flavor, Nano-Hydroxyapatite, Xanthan
Gum, Menthol, Sodium Benzoate, CarboxymethyI Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP-H202).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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66

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-002-01Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry65 g in 1 TUBEOINTMENT651
85215-002-02Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry12 in 1 BOXOINTMENT121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85215-002FLUORIDE ANTI CARIES 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY (FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY) OINTMENT [WORLD DENTISTS ASSOCIATION AMERICA LIMITED]1Current NDC, 2 package rows20250521_3573f149-2af9-4c86-e063-6294a90a7b3f.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85215-00285215-002-01, 85215-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
ndc (package): 85215-002-02
ndc (package): 85215-002-01
ndc (product): 85215-002
ndc11 (package): 85215000201
ndc11 (package): 85215000202
spl id: 3573e1bb-55ac-2f35-e063-6394a90a7fb7
spl set id: 3573f149-2af9-4c86-e063-6294a90a7b3f

Reported adverse events (FAERS/openFDA)#

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