FDA.reportPublic FDA data

85215-003

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:31

Label at a glance#

ProductSEXYTEETH CHARCOAL 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 dcntist 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 dcntist 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 dcntist or doctor.

Other information

STORAGE AND HANDLING SECTION

Store in a cool and shady place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica,Water/Aqua,PEG-8, Glycerin, Sodium Lauryl
Sulfate, Flavor/Aroma, Cellulose Gum, Xanthan Gum, Tetrasodium
Pyrophosphate, Sodium Saccharin,Sodium Fluoride,Charcoal
Powder, Sodium Bicarbonate, Mica, Methylparaben, 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-003-01SEXYTEETH CHARCOAL T00THPASTE113 g in 1 TUBEOINTMENT1131

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
85215-00385215-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
PEG-8B697894SGQIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CELLULOSE GUMK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM SACCHARINSB8ZUX40TYIACT
CHARCOAL POWDER2P3VWU3H10IACT
SODIUM BICARBONATE8MDF5V39QOIACT
MICAV8A1AW0880IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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 CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
ndc (package): 85215-003-01
ndc (product): 85215-003
ndc11 (package): 85215000301
spl id: 51ab8689-7dc0-a04d-e063-6294a90a324d
spl set id: 51ab8a9a-6c12-b13b-e063-6294a90ace2a

Reported adverse events (FAERS/openFDA)#

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