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).

Inactive ingredients

sorbitol, aqua, glycerin, hydrated silica, sodium lauryl sulfate, xanthan gum, citric acid, stevia rebaudiana leaf / stem extract, sodium benzoate, carica papaya leaf extract, camellia sinensis (green tea) leaf extract, potassium sorbate, caprylic/capric triglyceride*, ethyl butyrate*, ethyl 2-methylbutyrate*, ethyl acetate*, dimethyl heptenal*, *flavour (arôme) 1.

1 Contains limonene

QUESTIONS?

+1 (514) 509-7225

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

ATTITUDE™
natural care

for kids with fluoride

toothpaste
WATERMELON
Prevents cavities

ECO-CONSCIOUS

VEGAN

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: 61649-724
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)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
ETHYL 2-METHYLBUTYRATE (UNII: L1T4AB29DS)
ETHYL ACETATE (UNII: 76845O8NMZ)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)

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: 61649-724-01	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(61649-724) , label(61649-724) , pack(61649-724) , analysis(61649-724)