Eurofresh Whitening Paste, Dentifrice
FDA Label NDC 74690-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Farmasi Us Llc for the product Eurofresh Whitening (NDC 74690-008). 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 drug facts, active ingredients, purpose, use, warnings, do not use, keep out of reach of children, direction, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Sodium Fluoride - 0.24%

Purpose

Anticavity

Use

Helps protect against cavities

Helps whiten teeth

Warnings

Do Not Use

if irritation occurs and persists.

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.

Direction

  • Supervise children as necessary until capable of using without supervision.
  • Do not swallow.
  • Rinse away toothpaste residue thoroughly after brushing.
  • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
  • Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing).
  • Children under 2 years: ask a dentist or physician.

Inactive Ingredients

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca alternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora Persica Bark/Root Extract.

Package Labeling:

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