ALORA SENSITIVITY- potassium nitrate and sodium fluoride gel, dentifrice

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]

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Drug Facts

ACTIVE INGREDIENT

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

Uses

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

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

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

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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

INGREDIENTS AND APPEARANCE

ALORA   SENSITIVITY
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-309
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
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
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: 72288-309-02	3 in 1 PACKAGE, COMBINATION	10/01/2019
1	NDC: 72288-309-01	1 in 1 CARTON
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72288-309-03	6 in 1 PACKAGE, COMBINATION	10/01/2019
2	NDC: 72288-309-01	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

Labeler - Amazon, Inc (128990418)