OTC Medication Information: Alora Sensitivity Whitening

ALORA SENSITIVITY WHITENING- potassium nitrate and sodium fluoride gel, dentifrice
Ultradent Products, 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.

Drug Facts

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

Uses

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

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

Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)

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

SENSITIVITY

MINT

FLUORIDE TOOTHPASTE FOR
SENSITIVE TEETH
NET WT. 4 oz • 113 g

PRINCIPAL DISPLAY PANEL -- 113 g Tube Carton
(click image for full-size original)
ALORA SENSITIVITY WHITENING
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-309
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Nitrate (Nitrate Ion) Potassium Nitrate 50 mg in 1 g
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Silicon Dioxide
XYLITOL
Glycerin
SORBITOL
Methyl Salicylate
Poloxamer 407
Sodium Lauryl Sulfate
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
Sodium Benzoate
Sodium Hydroxide
Sucralose
Xanthan Gum
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Product Characteristics
Color GREEN Score
Shape Size
Flavor MINT (Cool Mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51206-309-02 3 CARTON6 CARTON in 1 PACKAGE, COMBINATION contains a CARTON (51206-309-01)
1 NDC:51206-309-03 3 CARTON6 CARTON in 1 PACKAGE, COMBINATION contains a CARTON (51206-309-01)
1 NDC:51206-309-01 1 TUBE in 1 CARTON This package is contained within the PACKAGE, COMBINATION (51206-309-02) and contains a TUBE
1 113 g in 1 TUBE This package is contained within a CARTON (51206-309-01) and a PACKAGE, COMBINATION (51206-309-02) and a PACKAGE, COMBINATION (51206-309-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 10/01/2019
Labeler — Ultradent Products, Inc. (013369913)
Establishment
Name Address ID/FEI Operations
Ultradent Products, Inc. 013369913 MANUFACTURE (51206-309), ANALYSIS (51206-309), LABEL (51206-309), PACK (51206-309)

Revised: 12/2020 Ultradent Products, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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