373 Rembrandt Intense Stain Mint Whitening Toothpaste

373 Rembrandt Intense Stain Mint Whitening Toothpaste
SPL v3
SPL
SPL Set ID 55dcd063-5661-35aa-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2021-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (24.3 mg)
Inactive Ingredients
Glycerin Hydrated Silica Water Sorbitol Potassium Pyrophosphate Titanium Dioxide Sodium Lauroyl Sarcosinate Carboxymethylcellulose Sodium, Unspecified Lauryl Glucoside Povidone, Unspecified Sodium Sulfate Cocamidopropyl Betaine Xanthan Gum Saccharin Sodium Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-25

Description

Sodium Fluoride (0.243%)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride (0.243%)

Use

Aids in the prevention of dental cavities.

Section 42229-5

Directions: updated use instructions 7/2/2019

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least 2 times 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 Fluoride (0.243%)

Other Information
  • Store at 20°-25°C (68°-77°F).
  • Do not use if inner foil is torn, cut or missing.
Inactive Ingredients

Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose.

Questions Or Comments?

Email [email protected], or call 800-548-3663.

Distributed by Ranir, LLC,

Grand Rapids, MI 49512

©2018 Ranir, LLC 80102AB

Principal Display Panel

I INTENSE STAIN®

REMBRANDT

WHITENING TOOTHPASTE WITH FLUORIDE

Mint

25x MORE STAIN REMOVED IN 1 WEEK

STRENGTHENS & RESTORES ENAMEL

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.

Section 42229-5 (42229-5)

Directions: updated use instructions 7/2/2019

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least 2 times 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 Fluoride (0.243%)

Other Information (Other information)
  • Store at 20°-25°C (68°-77°F).
  • Do not use if inner foil is torn, cut or missing.
Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Email [email protected], or call 800-548-3663.

Distributed by Ranir, LLC,

Grand Rapids, MI 49512

©2018 Ranir, LLC 80102AB

Principal Display Panel

I INTENSE STAIN®

REMBRANDT

WHITENING TOOTHPASTE WITH FLUORIDE

Mint

25x MORE STAIN REMOVED IN 1 WEEK

STRENGTHENS & RESTORES ENAMEL

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

All Sections (JSON)