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. Store at room temperature (15-30 °C).

Non-medicinal ingredients

Sorbitol, aqua, glycerin, hydrated silica, sodium lauryl sulfate, gaultheria procumbens (wintergreen) leaf oil 1, 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.

1 Naturally contains : D-limonene.

QUESTIONS?

+1 (514) 509-7225

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

ATTITUDE ®
bio spectra

natural care

anticavity with fluoride

toothpaste
ENAMEL CARE
Spearmint

EWG VERIFIED
FOR YOUR HEALTH EWG.ORG™

NPN 80104880

GEL 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)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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 final	part355	05/15/2021

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

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