Rembrandt D Deeply White® Plus Peroxide Drug Facts

Rembrandt D Deeply White® Plus Peroxide Drug Facts
SPL v1
SPL
SPL Set ID bf7da007-ab9d-4631-bc28-6ca245fd6265
Route
DENTAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.884 g)
Inactive Ingredients
Calcium Pyrophosphate Water Glycerin Polyethylene Glycol 400 Silicon Dioxide Hydrogen Peroxide Sodium Lauryl Sulfate Saccharin Sodium Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Citric Acid Monohydrate Sodium Citrate, Unspecified Form Sucralose Povidone, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-20

Description

Sodium Monofluorophosphate (0.884%)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate (0.884%)

Use

Aids in the prevention of dental cavities.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Use a pea-sized amount and instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. Do not swallow.

Active Ingredient

Sodium Monofluorophosphate (0.884%)

Other Information

Store at 20° - 25°C (68°-77°F).

Inactive Ingredients

calcium pyrophosphate, water, glycerin, PEG-8, colloidal silicon dioxide, hydrogen peroxide, flavor, sodium lauryl sulfate, sodium saccharin, cellulose gum, xanthan gum, citric acid, sodium citrate, sucralose, trisodium ethylenediamine, PVP

Package/label Principal Display Panel

D DEEPLY WHITE® + Peroxide

WHITER TEETH IN 3 DAYS

REMBRANDT®

ANTICAVITY FLUORIDE TOOTHPASTE WITH PEROXIDE

STRENGTHENS & RESTORES ENAMEL

Peppermint

NET WT 3.5 OZ (99.2 g)

Keep Out of Reach of Children Under 6 Years of Age.

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


Structured Label Content

Use

Aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Use a pea-sized amount and instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. Do not swallow.

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate (0.884%)

Other Information (Other information)

Store at 20° - 25°C (68°-77°F).

Inactive Ingredients (Inactive ingredients)

calcium pyrophosphate, water, glycerin, PEG-8, colloidal silicon dioxide, hydrogen peroxide, flavor, sodium lauryl sulfate, sodium saccharin, cellulose gum, xanthan gum, citric acid, sodium citrate, sucralose, trisodium ethylenediamine, PVP

Package/label Principal Display Panel (Package/Label Principal Display Panel)

D DEEPLY WHITE® + Peroxide

WHITER TEETH IN 3 DAYS

REMBRANDT®

ANTICAVITY FLUORIDE TOOTHPASTE WITH PEROXIDE

STRENGTHENS & RESTORES ENAMEL

Peppermint

NET WT 3.5 OZ (99.2 g)

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

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


Advanced Ingredient Data


Raw Label Data

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