Alora™ Whitening Toothpaste

Alora by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

----------

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

ALORA   WHITENING
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-310
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-310-02	3 in 1 PACKAGE, COMBINATION	10/01/2019	06/30/2022
1	NDC: 51206-310-01	1 in 1 CARTON
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-310-03	6 in 1 PACKAGE, COMBINATION	10/01/2019	06/30/2022
2	NDC: 51206-310-01	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	06/30/2022

Labeler - Ultradent Products, Inc (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
OraTech, LLC		827869285	MANUFACTURE(51206-310) , ANALYSIS(51206-310) , LABEL(51206-310) , PACK(51206-310)

Revised: 12/2023

Document Id: e2c0690b-1d63-443f-a318-7ae4e6b197da

34390-5

Set id: 48009c5a-22f7-4d00-b04e-cdfd8a06a8b7

Version: 4

Effective Time: 20231205