FDA.reportPublic FDA data

FreshMax Fluoride Kids

Manufacturer
International Wholesale Inc
Effective date
2019-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:00:58

Label at a glance#

ProductFreshMax Fluoride Kids
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Indications and uses

Aides in the prevention of dental cavities.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22% (Available fluoride content:1000ppm)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aides in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brusing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Silica, Polyethylene Glycol 400, Sodium Carboxymethylcellulose, Sodium Lauryl Alcohol Gum Flavor, Titanium Dioxide, Sodium Saccharin, Methyl Paraben, Propylparaben, Color: Pink

Other Information:

SPL UNCLASSIFIED SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52862-50252862-502-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
7d523511-b472-cc22-e053-2a91aa0a7ca449ae15b9-bce3-3aed-e054-00144ff88e882019-11-15WarningsExact identifier
spl id: 7d523511-b472-cc22-e053-2a91aa0a7ca4
spl set id: 49ae15b9-bce3-3aed-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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