Dr. Jen Superpaste Perio

Dr. Jen Superpaste Perio
SPL v1
SPL
SPL Set ID 8c7e6d3a-49d9-4098-9d5e-e9792b373574
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Glycerin Water Hydrated Silica Xylitol Tribasic Calcium Phosphate Cellulose Gum Menthol, Unspecified Form Stevia Rebaudiana Leaf Citric Acid Aloe Vera Leaf Illicium Verum Whole Papaya Black Cherry Glycyrrhiza Uralensis Root Spearmint Peppermint Menaquinone 6 Cholecalciferol Calendula Officinalis Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-13

Description

IMPORTANT: Read directions for proper use.


Medication Information

Warnings and Precautions

Warnings:

Indications and Usage

Use: Aids in the prevention of dental cavities

Dosage and Administration

Directions: Adults and children 2 years of

age and older: Brush teeth twice a day, with a

pea size amount for two minutes. Spit out

excess and do not rinse. Wait 30 minutes

before eating or drinking, or as directed by a

dentist or doctor. Instruct children under 6

years of age in good brushing and spitting

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.

Description

IMPORTANT: Read directions for proper use.

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.

Section 51727-6

Inactive Ingredients: Glycerin, Water,

Hydrated Silica, Xylitol, Nano-Hydroxy apatite,

Cellulose Gum, Spearmint Flavor, Menthol

Crystal, Stevia Rebaudiana Leaf Extract, Citric

Acid, Aloe Barbadensis (Aloe Vera), Illicium

verun (Anise) Extract, Papaya Extract, Prunus

Serotina (Black Cherry) Extract, Glycyrrhiza

Uralensis, (Chinese Licorice) Root Extract,

Mentha Spicata (Spearmint), Mentha Arvensis

(Peppermint), Vitamin K2, Vitamin D3,

Calendula

Section 55105-1

Purpose:

Sodium Fluoride - Anticavity

Section 55106-9

DRUG FACTS

Active Ingredient

Sodium Fluoride 0.22%

Section 60561-8

IMPORTANT:

Read directions for proper use.

Dr. Jen Superpaste Perio Product Package Labeling

++++++++++++++++++++++++++++++++

DR. JEN

SP



Super

Paste

PERIO

10% PREMIUM

NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

___________

Cool Mint

___________

3.4 FL. OZ. | 100 ML

DrJenNatural.com

Dr. Jen

St. Paul, MN 55118

Carton

Tube

res


Structured Label Content

Indications and Usage (34067-9)

Use: Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Directions: Adults and children 2 years of

age and older: Brush teeth twice a day, with a

pea size amount for two minutes. Spit out

excess and do not rinse. Wait 30 minutes

before eating or drinking, or as directed by a

dentist or doctor. Instruct children under 6

years of age in good brushing and spitting

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.

Warnings and Precautions (34071-1)

Warnings:

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.

Section 51727-6 (51727-6)

Inactive Ingredients: Glycerin, Water,

Hydrated Silica, Xylitol, Nano-Hydroxy apatite,

Cellulose Gum, Spearmint Flavor, Menthol

Crystal, Stevia Rebaudiana Leaf Extract, Citric

Acid, Aloe Barbadensis (Aloe Vera), Illicium

verun (Anise) Extract, Papaya Extract, Prunus

Serotina (Black Cherry) Extract, Glycyrrhiza

Uralensis, (Chinese Licorice) Root Extract,

Mentha Spicata (Spearmint), Mentha Arvensis

(Peppermint), Vitamin K2, Vitamin D3,

Calendula

Section 55105-1 (55105-1)

Purpose:

Sodium Fluoride - Anticavity

Section 55106-9 (55106-9)

DRUG FACTS

Active Ingredient

Sodium Fluoride 0.22%

Section 60561-8 (60561-8)

IMPORTANT:

Read directions for proper use.

Dr. Jen Superpaste Perio Product Package Labeling (Dr. Jen SuperPaste Perio Product Package Labeling)

++++++++++++++++++++++++++++++++

DR. JEN

SP



Super

Paste

PERIO

10% PREMIUM

NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

___________

Cool Mint

___________

3.4 FL. OZ. | 100 ML

DrJenNatural.com

Dr. Jen

St. Paul, MN 55118

Carton

Tube

res


Advanced Ingredient Data


Raw Label Data

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