85215-004

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2026-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:32

Label at a glance#

ProductSEXYTEETH MINTY T00THPASTE
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). For children under 2 years of age: Ask 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 0.24%(1000 PPM)
(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

As with all fluoride toothpaste, keep out of reach of
children under 6 years old. If you accidentally swallow
more than used for brushing, get medical help or call a
Poison Control Center right away.

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

For children under 2 years of age: Ask a dentist or doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over: Brush
teeth thoroughly after each meal or at least twice a
day, or as directed by a dentist or doctor.
Children under 6 years of age: Use a pea-sized
amount and supervise child's brushing and rinsing (to
minimize swallowing). For children under 2 years of
age: Ask a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

Store in a cool and shady place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate,Water/Aqua, Sorbitol, Sodium Lauryl Sulfate,
Hydrated Silica,PEG-8, Cellulose Gum, Flavor/Aroma,Sodium
Fluoride, Sodium Saccharin,Methylparaben, Sodium Phytate,
Propylparaben.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-004-01SEXYTEETH MINTY T00THPASTE113 g in 1 TUBEOINTMENT1131

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
85215-00485215-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
ndc (package): 85215-004-01
ndc (product): 85215-004
ndc11 (package): 85215000401
spl id: 51d27efb-8ac9-fed7-e063-6294a90ab0f1
spl set id: 51d288c1-fe86-ffe1-e063-6394a90ab4c4

Reported adverse events (FAERS/openFDA)#

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