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
Purpose

Anticavity toothpaste

Description

Drug Facts

Medication Information

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.
Inactive Ingredients

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

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.

Active Ingredient

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

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

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.
Inactive Ingredients (Inactive ingredients)

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

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.

Active Ingredient (Active ingredient)

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

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

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