Alora™ Whitening Toothpaste

Alora by

Drug Labeling and Warnings

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

Drug Details [pdf]

ALORA  WHITENING- 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™
Whitening Toothpaste

Drug Facts

Active Ingredients

Sodium Fluoride 0.25% w/w

Purpose

Anticavity

Uses

• Aids in the prevention of dental cavities.

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
• Contains FD&C Yellow No. 5 (tartrazine) as a color additive

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

MINT
NET WT. 4 oz 113 g

ALORA   WHITENING
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-306
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
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Sorbitol (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Hydroxide (UNII: 55X04QC32I)
Sucralose (UNII: 96K6UQ3ZD4)
Xanthan Gum (UNII: TTV12P4NEE)

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: 72288-306-09	3 in 1 PACKAGE, COMBINATION	10/01/2019	10/02/2019
1	NDC: 72288-306-08	1 in 1 CARTON
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72288-306-10	6 in 1 PACKAGE, COMBINATION	10/01/2019	10/02/2019
2	NDC: 72288-306-08	1 in 1 CARTON
2		28.35 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 NOT FINAL	part356	10/01/2019	10/02/2019

Labeler - Amazon, Inc (128990418)

Revised: 1/2020

Document Id: c0209e34-9563-442a-8275-bdca8e8f49ce

34390-5

Set id: e2304f30-15d0-42ec-b3cd-abe1b4811e77

Version: 2

Effective Time: 20200116

 

Amazon, Inc