ALORA  WHITENING- potassium nitrate and sodium fluoride gel, dentifrice 
Amazon, Inc

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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Alora™
Whitening Toothpaste

Drug Facts

Active Ingredients

Sodium Fluoride 0.25% w/w

Purpose

Anticavity

Uses

  • Aids in the prevention of dental cavities.

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 thoroughly, 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.

Other Information

  • Do not use if tamper-evident seal is broken
  • Store at room temperature
  • Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients

Carboxypolymethylene, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Flavor (aroma), Glycerin, Methyl Salicylate, Poloxamer 407, Potassium Nitrate, Silicon Dioxide, Sodium Benzoate, Sodium Hydroxide, Sodium Lauryl Sulfate, Sorbitol, Sucralose, Water (aqua), Xanthan Gum, Xylitol.

Questions or comments

Call toll-free 1-800-526-6880

Manufactured by: OraTech, LLC
10075 South Jordan Gateway, South Jordan, UT 84095

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

ALORA™

WHITENING
TOOTHPASTE

MINT
NET WT. 4 oz • 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
ALORA   WHITENING
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-306
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Sorbitol (UNII: 506T60A25R)  
Xylitol (UNII: VCQ006KQ1E)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sucralose (UNII: 96K6UQ3ZD4)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-306-093 in 1 PACKAGE, COMBINATION10/01/201910/02/2019
1NDC:72288-306-081 in 1 CARTON
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72288-306-106 in 1 PACKAGE, COMBINATION10/01/201910/02/2019
2NDC:72288-306-081 in 1 CARTON
228.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/01/201910/02/2019
Labeler - Amazon, Inc (128990418)

Revised: 1/2020
Document Id: c0209e34-9563-442a-8275-bdca8e8f49ce
Set id: e2304f30-15d0-42ec-b3cd-abe1b4811e77
Version: 2
Effective Time: 20200116
 
Amazon, Inc