Orazen Kids Anticavity Toothpaste

Orazen Kids Anticavity Toothpaste
SPL v2
SPL
SPL Set ID fa5b6bd8-443f-79e7-e053-6394a90a5513
Route
DENTAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Sorbitol Hydrated Silica Water Polyethylene Glycol 400 Carboxymethylcellulose Sodium Sodium Lauryl Sulfate Mica Sodium Benzoate Trisodium Phosphide Fd&c Blue No. 2 Potassium Sodium Saccharate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-04-01

Description

Active Ingredient                                Sodium Monofluorophosphate 0.76%


Medication Information

Warnings and Precautions

Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Indications and Usage

Use: Helps prevent against cavities

Dosage and Administration

Directions:adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist

Description

Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

[email protected]

Made in China/Hecho en China

Fabrique en Chine

Section 50565-1

 Keep out of reach of children under 6 years of age.

Section 51727-6

Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015

Section 51945-4

Ora-Zen Anticavity Toothpaste

Bubblegum

Section 55105-1

Purpose

Anti-Cavity Toothpaste

Section 55106-9

Active Ingredient                               

Sodium Monofluorophosphate 0.76%


Structured Label Content

Indications and Usage (34067-9)

Use: Helps prevent against cavities

Dosage and Administration (34068-7)

Directions:adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist

Warnings and Precautions (34071-1)

Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Description (34089-3)

Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

[email protected]

Made in China/Hecho en China

Fabrique en Chine

Section 50565-1 (50565-1)

 Keep out of reach of children under 6 years of age.

Section 51727-6 (51727-6)

Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015

Section 51945-4 (51945-4)

Ora-Zen Anticavity Toothpaste

Bubblegum

Section 55105-1 (55105-1)

Purpose

Anti-Cavity Toothpaste

Section 55106-9 (55106-9)

Active Ingredient                               

Sodium Monofluorophosphate 0.76%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)