Maximum®

Maximum®
SPL v2
SPL
SPL Set ID e29f30ec-72ea-4944-a2c2-b1696d31b639
Route
DENTAL
Published
Effective Date 2024-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.2 mg)
Inactive Ingredients
Water Sorbitol Carbomer Homopolymer, Unspecified Type Sodium Lauryl Sulfate Sodium Hydroxide Saccharin Sodium Sodium Benzoate Edetate Disodium Menthol, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-01
Description

Drug Facts

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

Helps protect against cavities.

Section 42229-5

Drug Facts

Section 50565-1

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions
Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years: Ask a dentist or physician.
Active Ingredient

Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)

Inactive Ingredients

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Menthol

Principal Display Panel 43 G Tube Label

MAXIMUM®

SECURITY

ANTICAVITY

GEL TOOTHPASTE

Sodium Fluoride 0.22%

Fresh Mint Flavor

NET WT 1.5 OZ. (43 g)

Structured Label Content

Use

Helps protect against cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Anticavity toothpaste

Directions
Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years: Ask a dentist or physician.
Active Ingredient (Active ingredient)

Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Menthol

Principal Display Panel 43 G Tube Label (PRINCIPAL DISPLAY PANEL - 43 g Tube Label)

MAXIMUM®

SECURITY

ANTICAVITY

GEL TOOTHPASTE

Sodium Fluoride 0.22%

Fresh Mint Flavor

NET WT 1.5 OZ. (43 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:49.914535 · Updated: 2026-03-14T23:02:36.495120