AURAGLOW WHITENING- sodium fluoride paste, dentifrice 
Auraglow LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Auraglow Whitening Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose  Anticavity

Use  Aids in prevention of dental cavities.

Warnings

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.

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 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

001 Crtn

001 Tube

res

AURAGLOW WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81740-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81740-001-011 in 1 CARTON07/01/2021
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/2021
Labeler - Auraglow LLC (066094893)
Registrant - Auraglow LLC (066094893)

Revised: 11/2022
Document Id: f1853564-157f-4646-8803-8d53ec932e17
Set id: 6b697a7e-bd57-4b02-8897-326c085b2bd8
Version: 2
Effective Time: 20221107
 
Auraglow LLC