AURAGLOW DAILY- 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 Daily 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

Deionized water, sorbitol, hydrated silica, xylitol,

glycerin, polyethylene glycol, sodium methyl

cocoyl taurate, flavor, cellulose gum, dimethicone,

monosodium phosphate, stevia, sodium benzoate

Package Labeling

​Auraglow

Daily

Toothpaste

Strengthens Teeth

and prevents cavities.

_____________________

Wintergreen

C​ONTAINS FLUORIDE

_____________________

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

002 Crtn

002 Btl

res

AURAGLOW DAILY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81740-002
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81740-002-011 in 1 CARTON08/01/2021
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 finalpart35508/01/2021
Labeler - Auraglow LLC (066094893)
Registrant - Auraglow LLC (066094893)

Revised: 11/2022
Document Id: 1a8ffb75-e8f5-4b32-9eee-2f47d0b61182
Set id: f9924be1-5467-4abc-8185-47bc11aef59e
Version: 2
Effective Time: 20221107
 
Auraglow LLC