ALORA  SENSITIVITY- 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
Sensitivity Toothpaste

Drug Facts

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

Uses

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

Other Information

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

SENSITIVITY

MINT

NET WT. 4 oz • 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
ALORA   SENSITIVITY
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-309
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
XYLITOL (UNII: VCQ006KQ1E)  
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Benzoate (UNII: OJ245FE5EU)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Sodium Hydroxide (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-309-023 in 1 PACKAGE, COMBINATION10/01/2019
1NDC:72288-309-011 in 1 CARTON
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72288-309-036 in 1 PACKAGE, COMBINATION10/01/2019
2NDC:72288-309-011 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 FINALpart35610/01/2019
Labeler - Amazon, Inc (128990418)

Revised: 9/2019
Document Id: 9cefa35a-c546-4fa6-8f87-43cf66a41530
Set id: 69bf4380-d014-4e94-bb96-73ecc5b0a2b0
Version: 1
Effective Time: 20190918
 
Amazon, Inc