FDA.reportPublic FDA data

CO Bigelow Alcohol Hand Sanitizer

Manufacturer
Ivresse Internacional, S.A. de C.V.
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:49:24

Label at a glance#

ProductCO Bigelow Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

To decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.

Dosage and administration

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70 % v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin when water, soap & towel are not available.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

  • Flammable. Keep away from heat or flame.

When using this product:

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.
  • Do not use on broken or irritated skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develop and last more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

SPL UNCLASSIFIED SECTION

  • Do not store above 105 °F (40°C)
  • May discolor certain fabrics and wood surfaces

Inactive ingredients:

INACTIVE INGREDIENT SECTION

water, carbomer, triethanolamine, glycerin, propylene glycol, aloe barbadensis leaf juice.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78740-00578740-005-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
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
053f02f1-a152-5713-e063-6394a90a953f304cf9bd-5fc6-440e-9298-23f198201f7c2023-09-13WarningsExact identifier
spl set id: 304cf9bd-5fc6-440e-9298-23f198201f7c

Reported adverse events (FAERS/openFDA)#

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