Auraglow Whitening Toothpaste

Auraglow Whitening Toothpaste
SPL v1
SPL
SPL Set ID 9d45e436-92f6-4a9e-9b82-329847dca9ba
Route
DENTAL
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.3 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Xylitol Cellulose Gum Sodium Lauroyl Sarcosinate Sodium Saccharin Carrageenan Titanium Dioxide Hydrogen Peroxide Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-20

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use   Helps protect against cavities

Dosage and Administration

Directions 

Adults and children 2 years of age and older:

Brush teeth thouroughly, 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

Section 42229-5

Drug Facts

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

Water, Sorbitol, Hydrated Silica, Glycerin,

Xylitol, Natural Wintergreen Flavor, Cellulose

Gum, Sodium Lauroyl Sarcosinate, Sodium

Saccharin, Carrargeenan, Titanium Dioxide,

Hydrogen Peroxide, Menthol

Section 55105-1

Purpose   Anticavity

Section 55106-9

Active ingredient

Sodium fluoride 0.23%

(0.15% w/v fluoride ion)

Package Labeling

​----------------------------------

Auraglow

Whitening

Toothpaste

Removes surface stains

and helps prevent cavities.

WINTERGREEN

FLUORIDE TOOTHPASTE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

CARTON

TUBE

res


Structured Label Content

Indications and Usage (34067-9)

Use   Helps protect against cavities

Dosage and Administration (34068-7)

Directions 

Adults and children 2 years of age and older:

Brush teeth thouroughly, 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

Section 42229-5 (42229-5)

Drug Facts

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

Water, Sorbitol, Hydrated Silica, Glycerin,

Xylitol, Natural Wintergreen Flavor, Cellulose

Gum, Sodium Lauroyl Sarcosinate, Sodium

Saccharin, Carrargeenan, Titanium Dioxide,

Hydrogen Peroxide, Menthol

Section 55105-1 (55105-1)

Purpose   Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium fluoride 0.23%

(0.15% w/v fluoride ion)

Package Labeling

​----------------------------------

Auraglow

Whitening

Toothpaste

Removes surface stains

and helps prevent cavities.

WINTERGREEN

FLUORIDE TOOTHPASTE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

CARTON

TUBE

res


Advanced Ingredient Data


Raw Label Data

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