Other
Drug Facts
Auraglow Whitening Paste, Dentifrice
FDA Label NDC 81740-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Auraglow Llc for the product Auraglow Whitening (NDC 81740-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Sodium fluoride 0.23%
(0.15% w/v fluoride ion)
Otc - Purpose
Purpose Anticavity
Indications & Usage
Use Helps protect against 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
Water, Sorbitol, Hydrated Silica, Glycerin,
Xylitol, Natural Wintergreen Flavor, Cellulose
Gum, Sodium Lauroyl Sarcosinate, Sodium
Saccharin, Carrargeenan, Titanium Dioxide,
Hydrogen Peroxide, Menthol
Package Labeling
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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
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