Dr. Jen Superpaste Ortho

Dr. Jen Superpaste Ortho
SPL v1
SPL
SPL Set ID 9dd248bf-9488-43cd-a041-e8315a05ce5d
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
Water Glycerin Hydrated Silica Xylitol Tribasic Calcium Phosphate Calcium Carbonate Carboxymethylcellulose Sodium, Unspecified Menthol Sodium Methyl Cocoyl Taurate Stevia Rebaudiana Leaf Citric Acid Aloe Vera Leaf Illicium Verum Whole Papaya Black Cherry Glycyrrhiza Uralensis Root Spearmint Peppermint Cholecalciferol Menaquinone 6 Calendula Officinalis Flower

Identifiers & Packaging

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

Description

DRUG FACTS Active Ingredient Sodium Fluoride 0.22%


Medication Information

Warnings and Precautions

Warnings:

If more than used for brushing is

accidentally swallowed, get

medical help or contact a Poison

Control Center right away.

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

DRUG FACTS Active Ingredient Sodium Fluoride 0.22%

Section 50565-1

Keep out of reach of children

under 6 years of age.

Section 51727-6

Inactive Ingredients: Water, Glycerin,

Hydrated Silica, Xylitol, Nano-Hydroxyapatite,

Calcium Carbonate, Sodium Carboxy-

methylcellulose, Natural Flavor, Menthol,

Sodium Methyl Cocoyl Taurate, Stevia

Rebaudiana Leaf Extract, Citric Acid, Aloe

Barbadensis (Aloe Vera), Illicium verum (Anise)

Extract, Papaya Extract, Prunus Serotina (Black

Cherry) Extract, Glycyrrhiza Uralensis (Chinese

Licorice) Root Extract, Mentha Spicata

(Spearmint), Mentha Arvensis (Peppermint),

Vitamin D3, Vitamin k2, Calendula

Section 55105-1

Purpose:

Sodium Fluoride - Anticavity

Section 55106-9

DRUG FACTS

Active Ingredient

Sodium Fluoride 0.22%

Dr. Jen Superpaste Product Package Labeling

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

​DR.JEN

SP

Super

Paste

ORTHO

10% PREMIUM

NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

___________

Cool Mint

___________

3.4 FL. OZ. | 100 ML

​DRJENNATURAL.COM

Dr. Jen

St. Paul, MN 55118

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:

If more than used for brushing is

accidentally swallowed, get

medical help or contact a Poison

Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

under 6 years of age.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Glycerin,

Hydrated Silica, Xylitol, Nano-Hydroxyapatite,

Calcium Carbonate, Sodium Carboxy-

methylcellulose, Natural Flavor, Menthol,

Sodium Methyl Cocoyl Taurate, Stevia

Rebaudiana Leaf Extract, Citric Acid, Aloe

Barbadensis (Aloe Vera), Illicium verum (Anise)

Extract, Papaya Extract, Prunus Serotina (Black

Cherry) Extract, Glycyrrhiza Uralensis (Chinese

Licorice) Root Extract, Mentha Spicata

(Spearmint), Mentha Arvensis (Peppermint),

Vitamin D3, Vitamin k2, Calendula

Section 55105-1 (55105-1)

Purpose:

Sodium Fluoride - Anticavity

Section 55106-9 (55106-9)

DRUG FACTS

Active Ingredient

Sodium Fluoride 0.22%

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

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

​DR.JEN

SP

Super

Paste

ORTHO

10% PREMIUM

NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

___________

Cool Mint

___________

3.4 FL. OZ. | 100 ML

​DRJENNATURAL.COM

Dr. Jen

St. Paul, MN 55118

res


Advanced Ingredient Data


Raw Label Data

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