Alora

Manufacturer
Amazon, Inc
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:04:45

Label at a glance#

ProductAlora Sensitivity
Active ingredientPotassium Nitrate, Sodium Fluoride
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Call toll-free 1-800-526-6880

SPL UNCLASSIFIED SECTION

Manufactured by: OraTech, LLC
10075 South Jordan Gateway, South Jordan, UT 84095

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALORA™

WHITENING
TOOTHPASTE

SENSITIVITY

MINT

NET WT. 4 oz • 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-309ALORA SENSITIVITY (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [AMAZON, INC]1Legacy NDC20191029_69bf4380-d014-4e94-bb96-73ecc5b0a2b0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-30972288-309-01, 72288-309-02, 72288-309-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45102532-4817-2a3f-e063-6394a90aceda69bf4380-d014-4e94-bb96-73ecc5b0a2b02025-12-03WarningsExact identifier
spl set id: 69bf4380-d014-4e94-bb96-73ecc5b0a2b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.