Alora™ Sensitivity Whitening Toothpaste

Alora by

Drug Labeling and Warnings

Alora by is a Otc medication manufactured, distributed, or labeled by Ultradent Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Alora™
Sensitivity Whitening Toothpaste

Drug Facts

Active Ingredients	Purpose
Potassium Nitrate 5% w/w	Anti-sensitivity
Sodium Fluoride 0.25% w/w	Anticavity

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

ALORA   SENSITIVITY WHITENING
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-309
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844)	Potassium Nitrate	50 mg  in 1 g
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-309-02	3 in 1 PACKAGE, COMBINATION	10/01/2019	10/31/2021
1	NDC: 51206-309-01	1 in 1 CARTON
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-309-03	6 in 1 PACKAGE, COMBINATION	10/01/2019	10/31/2021
2	NDC: 51206-309-01	1 in 1 CARTON
2		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M022	10/01/2019	10/31/2021

Labeler - Ultradent Products, Inc (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
OraTech, LLC		827869285	MANUFACTURE(51206-309) , ANALYSIS(51206-309) , LABEL(51206-309) , PACK(51206-309)

Revised: 12/2023

Document Id: 0b6b80cd-726b-4350-9658-ce21fa59da7f

34390-5

Set id: a4476b40-55bc-4ca3-a6fb-3ce7f3df8427

Version: 3

Effective Time: 20231205