BIO SPECTRA ATTITUDE .243 g/100g

Sodium fluoride · GEL, DENTIFRICE · 9055-7588 Quebec Inc. DBA Attitude

No Recall HistoryCurrently in Shortage

Plain English

BIO SPECTRA ATTITUDE is a gel, dentifrice containing sodium fluoride at .243 g/100g, taken dental. Manufactured by 9055-7588 Quebec Inc. DBA Attitude.

Key Facts

Brand Name: BIO SPECTRA ATTITUDE
Generic Name: Sodium fluoride
NDC Code (Product): 61649-730
Manufacturer: 9055-7588 Quebec Inc. DBA Attitude
Strength: .243 g/100g
Dosage Form: GEL, DENTIFRICE
Route: DENTAL
Marketing Status
Application #: M021
Marketing Start: 03/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective573 reports

pyrexia472 reports

macular degeneration453 reports

nausea442 reports

pain434 reports

off label use400 reports

weight decreased375 reports

headache326 reports

infusion related reaction307 reports

malaise292 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Helps prevent sunburn.

Dosage & Administration

Directions Adults and children older than 6 months. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Warnings

Warnings Allergens: soybeans (glycerin). For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.

Frequently Asked Questions

What is BIO SPECTRA ATTITUDE used for?

BIO SPECTRA ATTITUDE contains Sodium fluoride. It is a gel, dentifrice taken dental. Consult your doctor for specific uses.

Is BIO SPECTRA ATTITUDE a controlled substance?

BIO SPECTRA ATTITUDE is not classified as a controlled substance by the DEA.

What is the generic name for BIO SPECTRA ATTITUDE?

The generic name for BIO SPECTRA ATTITUDE is Sodium fluoride. There are 12 other brand versions of Sodium fluoride.

What is the NDC code for BIO SPECTRA ATTITUDE .243 g/100g?

The NDC (National Drug Code) for BIO SPECTRA ATTITUDE .243 g/100g is 61649-730, listed by 9055-7588 Quebec Inc. DBA Attitude.

Product NDC

61649-730

Package NDC

61649-730-01

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)