Bio Spectra Gel, Dentifrice
FDA Label NDC 61649-734

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 9055-7588 Qu�bec Inc. Dba Attitude for the product Bio Spectra (NDC 61649-734). 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, active ingredient, purpose, uses, otc - keep out of reach of children, directions, non-medicinal ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Active Ingredient

Sodium fluoride (0.243% w/w)

Purpose

Anti-cavity

Uses

  • Prevents, fights and protects against cavities and tooth decay.
  • Effective fluoride protection.
  • Protects teeth from acid erosion.
  • Penetrates tooth enamel to help rebuild weak spots.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

Do not swallow. Should be used as part of an oral health program that includes regular flossing and dental check-ups. Brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist. Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. Consult a dentist or health care professional before using with children under 2 years of age. Store at room temperature (15-30 °C).

Non-Medicinal Ingredients

Sorbitol, aqua, glycerin, hydrated silica, sodium lauryl sulfate, gaultheria procumbens (wintergreen) leaf oil

Naturally contains: D-limonene.

, xanthan gum, citric acid, sodium bicarbonate, stevia rebaudiana leaf / stem extract, sodium benzoate, carica papaya leaf extract, camellia sinensis (green tea) leaf extract, titanium dioxide, potassium sorbate.

Questions?

+1 (514) 509-7225

Principal Display Panel - 120 G Tube Label

bio spectra
ATTITUDE®
natural care

anticavity • with fluoride

toothpaste
ENAMEL CARE
Spearmint

• EWG VERIFIED •
FOR YOUR HEALTH • EWG.ORG

NPN 80104880
GEL • 120 g e 4.2 OZ.

* Please review the disclaimer below.