Auraglow Whitening Toothpaste

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (2.43 mg)

Inactive Ingredients

Sorbitol Hydrated Silica Water Glycerin Hydrogen Peroxide Polyethylene Glycol 1600 Sodium Tripolyphosphate Carboxymethylcellulose Sodium, Unspecified Sodium Methyl Cocoyl Taurate Stevia Rebaudiuna Leaf Sodium Bicarbonate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2021-07-01

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use Aids in prevention of dental 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

Sorbitol, hydrated silica, deionized water,

glycerin, hydrogen peroxide, polyethylene

glycol, sodium tripolyphosphate, cellulose

gum, sodium methyl cocoyl tautate,

flavor, stevia, sodium bicarbonate

Section 55105-1

Purpose Anticavity

Section 55106-9

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Package Labeling

Auraglow

Whitening Toothpaste

Wintergreen

CONTAINS FLUORIDE &

3% HYDROGEN PEROXIDE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

res

Structured Label Content

Indications and Usage (34067-9)

Use Aids in prevention of dental 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

Sorbitol, hydrated silica, deionized water,

glycerin, hydrogen peroxide, polyethylene

glycol, sodium tripolyphosphate, cellulose

gum, sodium methyl cocoyl tautate,

flavor, stevia, sodium bicarbonate

Section 55105-1 (55105-1)

Purpose Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Package Labeling

Auraglow

Whitening Toothpaste

Wintergreen

CONTAINS FLUORIDE &

3% HYDROGEN PEROXIDE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

res

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "2.43", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 1600", "unii": "1212Z7S33A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM TRIPOLYPHOSPHATE", "unii": "5HK03SA80J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM METHYL COCOYL TAURATE", "unii": "JVL98CG53G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIUNA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use Aids in prevention of dental cavities.", "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.", "34071-1": "Warnings", "42229-5": "Drug Facts", "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.", "51727-6": "Inactive Ingredients Sorbitol, hydrated silica, deionized water, glycerin, hydrogen peroxide, polyethylene glycol, sodium tripolyphosphate, cellulose gum, sodium methyl cocoyl tautate, flavor, stevia, sodium bicarbonate", "55105-1": "Purpose Anticavity", "55106-9": "Active ingredient Sodium fluoride 0.243% (0.15% w/v fluoride ion)", "Package Labeling": "Auraglow Whitening Toothpaste Wintergreen CONTAINS FLUORIDE & 3% HYDROGEN PEROXIDE NET WT 4.0 OZ (113G) Distr. by Auraglow LLC, Stamford, CT 06901 res"}

Auraglow Whitening Toothpaste

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information