FDA.reportPublic FDA data

BSafe Hand Sanitizer

Manufacturer
Original Gourmet Food Company
Effective date
2022-02-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:08:17

Label at a glance#

ProductBSafe Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

helps reduce bacteria on hands that potentially can cause disease  for use when soap and water are not available.

Dosage and administration

place enough product on hands to cover all surfaces rub hands together until dry. for children under 6, use adult supervision.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • helps reduce bacteria on hands that potentially can cause disease 
  • for use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from heat and flame.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age 
  • on open wounds

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears and mouth 
  • in case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be a sign of a serious condition.

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

  • place enough product on hands to cover all surfaces
  • rub hands together until dry.
  • for children under 6, use adult supervision.

Other information

SPL UNCLASSIFIED SECTION

  • store between 15-30 °C (59-86 °F)
  • avoid freezing and excessive heat about 40 °C (104 °F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer, Triethanolamine, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butylene Glycol, Artermisia Vulgaris Extract, Fragrance.

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:237ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79130-000-022022-02-21C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-082022-02-21C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-162022-02-21C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-332022-02-21C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-022022-01-28C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-082022-01-28C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-162022-01-28C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer
79130-000-332022-01-28C16284748780-1d6a99b39-aac0-a426-e053-dadaa90af4c2BSafe Hand Sanitizer

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
79130-00079130-000-02, 79130-000-08, 79130-000-16, 79130-000-33

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
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
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
f794887f-6eec-1047-e053-6294a90ad8dfa8fd5469-c9f2-46c1-e053-2995a90a53c62023-03-23WarningsExact identifier
spl set id: a8fd5469-c9f2-46c1-e053-2995a90a53c6

Reported adverse events (FAERS/openFDA)#

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