Dr. Jen Superpaste Nano-hydroxyapatite + Fluoride Toothpaste

Dr. Jen Superpaste Nano-hydroxyapatite + Fluoride Toothpaste
SPL v2
SPL
SPL Set ID 8b28b857-9162-4065-b0a0-571efffe9787
Route
ORAL
Published
Effective Date 2024-03-28
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 Sodium Methyl Cocoyl Taurate Carboxymethylcellulose Sodium, Unspecified Stevia Rebaudiuna Leaf Citric Acid Monohydrate Star Anise Fruit Carica Papaya Leaf Prunus Serotina Bark Glycyrrhiza Uralensis Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-21

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 thoroughly, preferably after

each meal or at least twice a day,

or as directed by a dentist or

doctor. Instruct children under 6

years of age 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.

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 Methyl Cocoyl

Taurate, Sodium Carboxymethyl-

cellulose, Natural Strawberry Flavor,

Stevia Rebaudiana Leaf Extract, Citric

Acid, Illicium Verum (Anise) Fruit

Extract, Carica Papaya Extract, Prunus

Serotina (Black Cherry) Bark Extract,

Glycyrrhiza Uralensis (Chinese Licorice)

Root Extract

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

Super Paste

TRIPLE CAVITY

PROTECTION

10% NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

Strawberry

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 thoroughly, preferably after

each meal or at least twice a day,

or as directed by a dentist or

doctor. Instruct children under 6

years of age 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.

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 Methyl Cocoyl

Taurate, Sodium Carboxymethyl-

cellulose, Natural Strawberry Flavor,

Stevia Rebaudiana Leaf Extract, Citric

Acid, Illicium Verum (Anise) Fruit

Extract, Carica Papaya Extract, Prunus

Serotina (Black Cherry) Bark Extract,

Glycyrrhiza Uralensis (Chinese Licorice)

Root Extract

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

Super Paste

TRIPLE CAVITY

PROTECTION

10% NANO-HYDROXYAPATITE,

FLUORIDE & XYLITOL

TOOTHPASTE

Strawberry

3.4 FL. OZ. | 100 ML

DrJenNatural.com

Dr. Jen

St. Paul, MN 55118

res


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