85215-005

Manufacturer
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Effective date
2026-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-11 01:01:39

Label at a glance#

ProductFreshness Coffee Toothpaste100g
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 0.243%W/W
(equivalent to 1100 ppm f.)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Helps protect against cavities.

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

If you have an allergic reaction after using this product, please stop using it immediately and see a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep it out of the reach of children.

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

Sorbitol,Water, Hydrated Silica, Glycerin, Sodium
Lauroyl Sarcosinate,Flavor/Aroma,Xanthan Gum,
Xylitol, Benzyl Alcohol, Sodium Fluoride,
Tetrapotassium Pyrophosphate, Cellulose Gum,
Caprylyl Glycol, Pentylene Glycol,Zinc Lactate,
Sodium Gluconate, Benzoic Acid, Methyl
Diisopropyl Propionamide, Sucralose,Disodium
Hydrogen Phosphate,Caramel Color (Pigment).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

labellabel

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqr.me-qr.com/X7FM7WVGlabel 1.jpg, label.jpg

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85215-00585215-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
Freshness Coffee Toothpaste100gFRESHNESS COFFEE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d79e9-2f0f-fa72-e063-6394a90a8dea2026-08-06WarningsExact identifier
ndc (package): 85215-005-01
ndc (product): 85215-005
ndc11 (package): 85215000501
spl id: 586d581b-42f2-dd6c-e063-6394a90a582e
spl set id: 586d79e9-2f0f-fa72-e063-6394a90a8dea

Reported adverse events (FAERS/openFDA)#

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