FDA.reportPublic FDA data

BIO SPECTRA

Manufacturer
9055-7588 Québec Inc. DBA ATTITUDE
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:35

Label at a glance#

ProductBIO SPECTRA ATTITUDE
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride (0.243% w/w)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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?

OTC - QUESTIONS SECTION

Questions? +1-855-509-7225

RECENT MAJOR CHANGES SECTION

Update of the storage conditions.

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATTITUDE ®

natural care

EWG Verified

Vegan

with fluoride

toothpaste

Spearmint
ENAMEL CARE
Super leaves TM

NPN 80104880

120 g / 4.2 OZ.

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN4
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-734-01BIO SPECTRAATTITUDE120 g in 1 TUBEGEL, DENTIFRICE1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-734BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUÉBEC INC. DBA ATTITUDE]4Current NDC, Legacy NDC, 1 package rows20240516_fefc1060-e1a4-4686-a8d8-84bf1e613abe.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-73461649-734-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYL SALICYLATELAV5U5022YIACT
XANTHAN GUMTTV12P4NEEIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
REBAUDIOSIDE AB3FUD0528FIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARICA PAPAYA LEAF66J7636Z2IIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
ndc (package): 61649-734-01
ndc (product): 61649-734
ndc11 (package): 61649073401
spl id: 186f0053-8c9b-d8b5-e063-6394a90af1c1
spl set id: fefc1060-e1a4-4686-a8d8-84bf1e613abe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.