Opalescence™ Sensitivity Relief Whitening Toothpaste

Opalescence™ Sensitivity Relief Whitening Toothpaste
SPL v11
SPL
SPL Set ID b5176a84-76a3-4ad0-a2e2-4997a12da9a5
Route
DENTAL
Published
Effective Date 2022-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Glycerin Xanthan Gum Water Sorbitol Sodium Hydroxide Xylitol Sodium Benzoate Sucralose Silicon Dioxide Methyl Salicylate Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-11-30 Until 2030-10-13

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Aids in the prevention of dental cavities.
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 55105-1
Active Ingredients Purpose
Potassium Nitrate 5% w/w Antihypersensitivity
Sodium Fluoride 0.25% w/w Anticavity
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.

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 1.800.552.5512

Principal Display Panel 133 G Tube Carton

Opalescence

whitening toothpaste

Cool Mint

Sensitivity

Relief

NET WT. 4.7 oz • 133 g • 100 ml

FLUORIDE TOOTHPASTE

FOR SENSITIVE TEETH


Structured Label Content

Uses
  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Aids in the prevention of dental cavities.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 55105-1 (55105-1)
Active Ingredients Purpose
Potassium Nitrate 5% w/w Antihypersensitivity
Sodium Fluoride 0.25% w/w Anticavity
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.

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 (Questions or comments)

Call toll-free 1.800.552.5512

Principal Display Panel 133 G Tube Carton (PRINCIPAL DISPLAY PANEL - 133 g Tube Carton)

Opalescence

whitening toothpaste

Cool Mint

Sensitivity

Relief

NET WT. 4.7 oz • 133 g • 100 ml

FLUORIDE TOOTHPASTE

FOR SENSITIVE TEETH


Advanced Ingredient Data


Raw Label Data

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