BIO SPECTRA  ATTITUDE- sodium fluoride gel, dentifrice 
Attitude DBA 9055-7588 Québec Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BIO SPECTRA
ATTITUDE®

DRUG FACTS

Active ingredient

Sodium fluoride (0.243% w/w)

Purpose

Anti-cavity

Uses

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, titanium dioxide, potassium sorbate, ethyl butyrate (fruit), butyl isovalerate (fruit), gamma decalactone (fruit).

QUESTIONS?

+1 (514) 509-7225

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

ATTITUDE®
bio spectra
natural care

for kids • with fluoride

toothpaste
BLUEBERRY
Prevents cavities

VEGAN

NPN 80104880
GEL • 120 g e 4.2 OZ.

Principal Display Panel - 120 g Tube Label
BIO SPECTRA   ATTITUDE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-723
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium fluoride0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Titanium dioxide (UNII: 15FIX9V2JP)  
Potassium sorbate (UNII: 1VPU26JZZ4)  
Ethyl butyrate (UNII: UFD2LZ005D)  
Butyl isovalerate (UNII: 4UX6V9QM2J)  
.Gamma.-Decalactone (UNII: 7HLS05KP9O)  
Product Characteristics
ColorWHITE (Opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61649-723-01120 g in 1 TUBE; Type 0: Not a Combination Product05/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/15/2021
Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)
Establishment
NameAddressID/FEIBusiness Operations
Attitude DBA 9055-7588 Québec Inc.204307099MANUFACTURE(61649-723) , LABEL(61649-723) , PACK(61649-723) , ANALYSIS(61649-723)
Establishment
NameAddressID/FEIBusiness Operations
Attitude DBA 9055-7588 Québec Inc.201137051MANUFACTURE(61649-723) , ANALYSIS(61649-723)

Revised: 6/2022
Document Id: 2ecb4906-6d2b-40a4-bd81-dd7e1f63bbba
Set id: 54bd43c9-489d-4e6b-9031-90ec0e3c4516
Version: 2
Effective Time: 20220602
 
Attitude DBA 9055-7588 Québec Inc.