Indications and uses
Aids in the prevention of dental cavities.
Alora
- Manufacturer
- Ultradent Products, Inc | OraTech, LLC
- Effective date
- 2022-01-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:13:28
Label at a glance#
ProductAlora Whitening
Active ingredientSodium Fluoride
Label structure11 sections
Dosage and administration
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.
Storage and handling
Do not use if tamper-evident seal is broken Store at room temperature
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Sodium Fluoride 0.25% w/w
Purpose
Anticavity
Uses
- Aids in the prevention of dental cavities.
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
SPL UNCLASSIFIED SECTION
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
Products#
Every source-derived product name is available through these pages.
- Alora Whitening
- Sodium Fluoride
- Fluoride Ion
- Glycerin
- Water
- Silicon Dioxide
- Sorbitol
- Xylitol
- Methyl Salicylate
- Sodium Lauryl Sulfate
- Poloxamer 407
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- Sodium Benzoate
- Sodium Hydroxide
- Sucralose
- Xanthan Gum
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51206-310 | 51206-310-01, 51206-310-02, 51206-310-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e2c0690b-1d63-443f-a318-7ae4e6b197da | 48009c5a-22f7-4d00-b04e-cdfd8a06a8b7 | 2023-12-05 | Warnings | 48009c5a-22f7-4d00-b04e-cdfd8a06a8b7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.