ALORA  WHITENING- sodium fluoride gel, dentifrice 
Ultradent Products, Inc

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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.

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 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

Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (Aroma), Sodium Lauryl Sulfate, Poloxamer 407, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), Sparkle (CI 77019, CI 77891).

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

ORIGINAL

MINT

FLUORIDE WHITENING TOOTHPASTE

NET WT. 4 oz • 113 g

Principal Display Panel - 113 g Tube Carton
ALORA   WHITENING
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-310
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sucralose (UNII: 96K6UQ3ZD4)  
Xanthan Gum (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-310-023 in 1 PACKAGE, COMBINATION10/01/201906/30/2022
1NDC:51206-310-011 in 1 CARTON
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51206-310-036 in 1 PACKAGE, COMBINATION10/01/201906/30/2022
2NDC:51206-310-011 in 1 CARTON
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02210/01/201906/30/2022
Labeler - Ultradent Products, Inc (013369913)
Establishment
NameAddressID/FEIBusiness Operations
OraTech, LLC827869285MANUFACTURE(51206-310) , ANALYSIS(51206-310) , LABEL(51206-310) , PACK(51206-310)

Revised: 12/2023
Document Id: e2c0690b-1d63-443f-a318-7ae4e6b197da
Set id: 48009c5a-22f7-4d00-b04e-cdfd8a06a8b7
Version: 4
Effective Time: 20231205
 
Ultradent Products, Inc