Freshen Up Anticavity Fluoride Toothpaste Max+ Whitening

Freshen Up Anticavity Fluoride Toothpaste Max+ Whitening
SPL v2
SPL
SPL Set ID 2dcd4816-caa5-c006-e063-6394a90ac487
Route
DENTAL
Published
Effective Date 2019-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (24 mg)
Inactive Ingredients
Hydroxypropyl Methylcellulose Benzyl Alcohol Sodium Lauryl Sulfate Sodium Benzoate Sorbitol Water Hydrated Silica Peg-32 Saccharin Sodium Cellulose Gum Tetrasodium Pyrophosphate Cocamidopropyl Betaine Tetrapotassium Pyrophosphate Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-10

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of 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 right away.

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
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
Questions?

1-888-880-1504

Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, cellulose gum, cocamidopropyl betaine, sodium saccharin,hydroxypropyl methylcellulose, FD&C blue no. 1,titanium dioxide, benzyl alcohol,tetra potassium pyrophosphate

Principal Display Panel 130 G Bottle Label


Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of 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 right away.

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
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
Questions?

1-888-880-1504

Active Ingredient (Active ingredient)

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, cellulose gum, cocamidopropyl betaine, sodium saccharin,hydroxypropyl methylcellulose, FD&C blue no. 1,titanium dioxide, benzyl alcohol,tetra potassium pyrophosphate

Principal Display Panel 130 G Bottle Label (PRINCIPAL DISPLAY PANEL - 130 g Bottle Label)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)