FreshMax Fluoride Minty Flavor

Manufacturer
International Wholesale Inc
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:43:29

Label at a glance#

ProductFreshMax Fluoride Minty Flavor
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Indications and uses

Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

Dosage and administration

Brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age to use a pea size amount. Supervise child’s brushing and rinsing (to minimize swallowing.) Consult a dentist or physician. Adults and children 2 years of age or older: Children under 6 years: Children under 2 years of age:

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

(Available fluoride content:1000ppm)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age to use a pea size amount. Supervise child’s brushing and rinsing (to minimize swallowing.) Consult a dentist or physician. Adults and children 2 years of age or older: Children under 6 years: Children under 2 years of age:

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Polyethylene Glycol 400, Sodium Carboxymethylcellulose, Silica, Gypsum Powder, Sodium Saccharin, Sodium Lauryl Alcohol, Flavor, Methyl Paraben, Propylparaben, Color: Bright Blue.

Other Information:

SPL UNCLASSIFIED SECTION

Lot No. & Expiration Date: See box or crimp of tube.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-501FRESHMAX FLUORIDE MINTY FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE [INTERNATIONAL WHOLESALE INC]6Legacy NDC20250108_499bbbbc-d301-33b3-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52862-50152862-501-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
3edb0e24-7812-28fa-e063-6394a90ac21b499bbbbc-d301-33b3-e054-00144ff88e882025-09-15WarningsExact identifier
spl set id: 499bbbbc-d301-33b3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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