FDA.reportPublic FDA data

BIO SPECTRA

Manufacturer
BIO SPECTRA | Les Entreprises Stefmar Inc.
Effective date
2024-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:15:28

Label at a glance#

ProductBIO SPECTRA ATTITUDE
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children under 6 when they use this product.

Storage and handling

Store between 15-30 °C (59-86 F). Avoid freezing and excessive heat above 40 °C (104 F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol (72% w/w)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

  • When using this product avoidcontact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

  • Stop use and consult a health care professionalif irritation or redness develops and persists for more than 72 hours.

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.

SPL UNCLASSIFIED SECTION

  • Flammability warningKeep away from open flame and sources of heat.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children under 6 when they use this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30 °C (59-86 F).
  • Avoid freezing and excessive heat above 40 °C (104 F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, nasturtium officinale extract, tropaeolum majus extract, citrus aurantium dulcis (orange) leaf extract, decanal, pentadecalactone, raspberry ketone.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bio spectra
ATTITUDE ®

SUPER
leaves™
science

hand sanitizer
ORANGE LEAVES
KILLS HARMFUL BACTERIA AND GERMS

• EWG VERIFIED •
FOR YOUR HEALTH •
EWG.ORG

100 mL ℮ 3.38 FL. OZ.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-39861649-398-01, 61649-398-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
NASTURTIUM OFFICINALEYH89GMV676IACT
TROPAEOLUM MAJUS WHOLE9G6ZOS4L87IACT
CITRUS SINENSIS LEAFVF01D90MZIIACT
DECANAL31Z90Q7KQJIACT
PENTADECALACTONEOK17S3S98KIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
ALCOHOL3K9958V90MACTIB

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
0e84924c-69ea-2aae-e063-6294a90a1b0d8e73891a-cf91-4801-b3bd-4ab1d1868c042024-01-09WarningsExact identifier
spl id: 0e84924c-69ea-2aae-e063-6294a90a1b0d
spl set id: 8e73891a-cf91-4801-b3bd-4ab1d1868c04

Reported adverse events (FAERS/openFDA)#

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