ALORA  SENSITIVITY WHITENING- potassium nitrate and sodium fluoride gel, dentifrice 
Ultradent Products, Inc

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Alora™
Sensitivity Whitening Toothpaste

Drug Facts

Active IngredientsPurpose
Potassium Nitrate 5% w/wAnti-sensitivity
Sodium Fluoride 0.25% w/wAnticavity

Uses

  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Aids in the prevention of dental cavities.

Warnings

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 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

Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)

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

SENSITIVITY

MINT

FLUORIDE TOOTHPASTE FOR
SENSITIVE TEETH
NET WT. 4 oz • 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
ALORA   SENSITIVITY WHITENING
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-309
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
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
XYLITOL (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-309-023 in 1 PACKAGE, COMBINATION10/01/201910/31/2021
1NDC:51206-309-011 in 1 CARTON
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51206-309-036 in 1 PACKAGE, COMBINATION10/01/201910/31/2021
2NDC:51206-309-011 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 drugM02210/01/201910/31/2021
Labeler - Ultradent Products, Inc (013369913)
Establishment
NameAddressID/FEIBusiness Operations
OraTech, LLC827869285MANUFACTURE(51206-309) , ANALYSIS(51206-309) , LABEL(51206-309) , PACK(51206-309)

Revised: 12/2023
Document Id: 0b6b80cd-726b-4350-9658-ce21fa59da7f
Set id: a4476b40-55bc-4ca3-a6fb-3ce7f3df8427
Version: 3
Effective Time: 20231205
 
Ultradent Products, Inc