Opalescence Sensitivity Relief Whitening Gel, Dentifrice
FDA Label NDC 51206-308

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ultradent Products, Inc. for the product Opalescence Sensitivity Relief Whitening (NDC 51206-308). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA

Otc - Purpose

Active IngredientsPurpose
Potassium Nitrate 5% w/wAntihypersensitivity
Sodium Fluoride 0.25% w/wAnticavity

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.

Otc - Keep Out Of Reach Of Children

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 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

Principal Display Panel (133 g Tube Carton)

Principal Display Panel (133 g Tube Carton)

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