FDA.reportPublic FDA data

BIO SPECTRA

Manufacturer
BIO SPECTRA | Les Entreprises Stefmar Inc.
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:07:13

Label at a glance#

ProductBIO SPECTRA ATTITUDE
Active ingredientalcohol
Label structure13 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 avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

  • Stop use and consult a health care professional if 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 warning Keep 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, vaccinium angustifolium (blueberry) leaf extract, triethyl citrate, gamma-undecalactone, hexyl acetate, vanillin.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATTITUDE®
bio spectra

little
leaves™
science

hand sanitizer
VANILLA & PEAR
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 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-31561649-315-01, 61649-315-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
VACCINIUM ANGUSTIFOLIUM LEAFB4L873GNG1IACT
Triethyl citrate8Z96QXD6UMIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
Hexyl acetate7U7KU3MWT0IACT
VanillinCHI530446XIACT

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
9ffd801c-097a-417e-b04a-28154d1c824bedef1ecf-eb0d-4162-88b9-cfd3a70174ae2020-11-12WarningsExact identifier
spl id: 9ffd801c-097a-417e-b04a-28154d1c824b
spl set id: edef1ecf-eb0d-4162-88b9-cfd3a70174ae

Reported adverse events (FAERS/openFDA)#

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