BIO SPECTRA ATTITUDE- sodium fluoride gel, dentifrice

BIO SPECTRA by

Drug Labeling and Warnings

BIO SPECTRA by is a Otc medication manufactured, distributed, or labeled by Attitude DBA 9055-7588 Québec Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

Warnings

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.

INACTIVE INGREDIENT

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

QUESTIONS?

Questions? +1-855-509-7225

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

ATTITUDE ®

natural care

EWG Verified

Vegan

with fluoride

toothpaste

Spearmint
ENAMEL CARE
Super leaves TM

NPN 80104880

120 g / 4.2 OZ.

INGREDIENTS AND APPEARANCE

BIO SPECTRA  ATTITUDE
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-734
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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
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: 61649-734-01	120 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/15/2021

Labeler - 9055-7588 Québec Inc. DBA ATTITUDE (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
9055-7588 Québec Inc. DBA ATTITUDE		204307099	manufacture(61649-734) , label(61649-734) , pack(61649-734) , analysis(61649-734)