Freshen-up Real Cavity Protection

Freshen-up Real Cavity Protection
SPL v1
SPL
SPL Set ID 476f453b-9215-0a11-e063-6294a90a5cd4
Route
DENTAL
Published
Effective Date 2019-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Benzyl Alcohol Sodium Lauryl Sulfate Sodium Saccharin Sorbitol Water Hydrated Silica Peg-400 Xanthan Gum Tetrasodium Pyrophosphate Carboxymethylcellulose Sodium Sodium Silicate Titanium Dioxide Ci 42090

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-02
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.

Warnings

Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use

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 physician or dentist
children 2 to 6 years use only a pea siz 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 Monofluorophosphate (0.76%)........Anticavity

Total Fluoride content- 1000 ppm appx.

Inactive Ingredients

calcium carbonate, water, sorbitol, silica, SLS, flavor, sodium silicate, tetrasodium pyrophosphate, xanthum gum, sodium carboxymethylcellulose, benzyl alcohol, sodium benzoate, sodium bicarbonate, sodium saccharin, titanium dioxide, peg-400, blue 1

Principal Display Panel

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

Warnings

Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use

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 physician or dentist
children 2 to 6 years use only a pea siz 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 Monofluorophosphate (0.76%)........Anticavity

Total Fluoride content- 1000 ppm appx.

Inactive Ingredients (Inactive ingredients)

calcium carbonate, water, sorbitol, silica, SLS, flavor, sodium silicate, tetrasodium pyrophosphate, xanthum gum, sodium carboxymethylcellulose, benzyl alcohol, sodium benzoate, sodium bicarbonate, sodium saccharin, titanium dioxide, peg-400, blue 1

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:04.760339 · Updated: 2026-03-14T23:12:12.345571