FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Lubdeco S.A. de C.V.
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:26:46

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

INACTIVE INGREDIENT SECTION

Carbomer

Triethanolamine

Glycerin

Purified Water

INDICATIONS & USAGE SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age using this product to avoid swallowing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Antiseptic

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1L NDC: 78763-101-01 1 Litter Bottle1 Litter Bottle

3.78L NDC: 78763-101-04 1 Gallon Bottle1 Gallon Bottle

2.5ml NDC: 78763-101-99 2.5ml Packet2.5ml Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78763-101-012022-01-28C16284748780-1d6a99b39-94c9-a426-e053-dadaa90af4c2Hand Sanitizer
78763-101-042022-01-28C16284748780-1d6a99b39-94c9-a426-e053-dadaa90af4c2Hand Sanitizer
78763-101-992022-01-28C16284748780-1d6a99b39-94c9-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78763-101-01Hand Sanitizer1 mL in 1 BOTTLELIQUID12
78763-101-04Hand Sanitizer3.78 mL in 1 BOTTLELIQUID3.782
78763-101-99Hand Sanitizer2.5 mL in 1 PACKETLIQUID2.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78763-101HAND SANITIZER (ETHYL ALCOHOL) LIQUID [LUBDECO S.A. DE C.V.]2Legacy NDC, 3 package rows20200904_a73a8acd-057e-4fb5-e053-2995a90aaac9.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78763-10178763-101-01, 78763-101-04, 78763-101-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
WATER059QF0KO0RIACT
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
ae6a43c6-8a46-04e3-e053-2a95a90a8d84a73a8acd-057e-4fb5-e053-2995a90aaac92020-09-03WarningsExact identifier
spl id: ae6a43c6-8a46-04e3-e053-2a95a90a8d84
spl set id: a73a8acd-057e-4fb5-e053-2995a90aaac9

Reported adverse events (FAERS/openFDA)#

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