FDA Label for Auraglow Whitening

View Indications, Usage & Precautions

Auraglow Whitening Product Label

The following document was submitted to the FDA by the labeler of this product Auraglow Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)


Otc - Purpose



Purpose  Anticavity


Indications & Usage



Use  Aids in prevention of dental cavities.


Warnings



Warnings


Otc - Keep Out Of Reach Of Children



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.


Dosage & 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.


Inactive Ingredient



Inactive Ingredients

Sorbitol, hydrated silica, deionized water,

glycerin, hydrogen peroxide, polyethylene

glycol, sodium tripolyphosphate, cellulose

gum, sodium methyl cocoyl tautate,

flavor, stevia, sodium bicarbonate


Package Labeling



​Auraglow

Whitening Toothpaste

Wintergreen

C​ONTAINS FLUORIDE &

3% HYDROGEN PEROXIDE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

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