BIO SPECTRA ATTITUDE- sodium fluoride and potassium nitrate paste, dentifrice

BIO SPECTRA by

Drug Labeling and Warnings

BIO SPECTRA by is a Otc medication manufactured, distributed, or labeled by BIO SPECTRA, Les Entreprises Stefmar Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active ingredients	Purpose
Sodium fluoride (0.243% w/w)	Anti-cavity
Potassium nitrate (5% w/w)	Anti-hypersensitivity

Uses

• Builds protection against sensitivity of the teeth.
• Shields and soothes dental nerves for lasting sensitivity relief when used regularly.
• Prevents, fights and protects against cavities.
• Effective fluoride protection.
• Protects teeth from acid erosion.
• Penetrates tooth enamel to help rebuild weak spots.

Warnings

Keep out of reach of children.

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

Sensitive teeth may indicate a serious problem. Stop use and consult a health care professional ifsymptoms persist or worsen.

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 or health care professional. Not recommended for children under 12 years of age. Store at room temperature (15-30 °C).

Non-medicinal ingredients

Aqua / Water / Eau, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Citric Acid, Xanthan Gum, Rebaudioside A, Sodium Benzoate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract.

QUESTIONS?

+1-855-509-7225

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

ATTITUDE ®
natural care

EWG VERIFIED

Vegan

with fluoride

toothpaste
Spearmint

SENSITIVE

Super Leaves

NPN 80104614

120 g 4.2 OZ.

INGREDIENTS AND APPEARANCE

BIO SPECTRA  ATTITUDE
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-733
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
REBAUDIOSIDE A (UNII: B3FUD0528F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-733-01	120 g in 1 TUBE; Type 0: Not a Combination Product	04/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/26/2024

Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
9055-7588 Quebec Inc. DBA Attitude		204307099	manufacture(61649-733) , label(61649-733) , pack(61649-733) , analysis(61649-733)