FDA.reportPublic FDA data

LATHER HAND SANITIZER

Manufacturer
SOMBRA COSMETICS
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:13

Label at a glance#

ProductLATHER HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use, when hand washing is not available.

Dosage and administration

Wet hands thoroughly and allow to dry without wiping.

Storage and handling

Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use, when hand washing is not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When Using

OTC - WHEN USING SECTION

Keep out of the eyes.  In case of contact with eyes, flush thoroughly with water.  Avoid contact with broken skin. Do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop. Condition persists more than 72  hours.

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.  For children under 6, use only under adult supervision.  Not recommended for infants.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract, filipendula rubra extract, camellia sinensis (green tea) leaf extract.

Purpose

OTC - PURPOSE SECTION

Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Los Poblanos 8oz gelLos Poblanos 8oz gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1114-22024-01-30C16284748780-11030e365-16dd-111a-e063-dadaa90a10e2Lather Hand Sanitizer
61577-1114-32024-01-30C16284748780-11030e365-16dd-111a-e063-dadaa90a10e2Lather Hand Sanitizer
61577-1114-42024-01-30C16284748780-11030e365-16dd-111a-e063-dadaa90a10e2Lather Hand Sanitizer
61577-1114-62024-01-30C16284748780-11030e365-16dd-111a-e063-dadaa90a10e2Lather Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1114-2LATHER HAND SANITIZER59 mL in 1 BOTTLE, PLASTICGEL591
61577-1114-3LATHER HAND SANITIZER296 mL in 1 BOTTLE, PUMPGEL2961
61577-1114-4LATHER HAND SANITIZER236 mL in 1 BOTTLE, PUMPGEL2361
61577-1114-6LATHER HAND SANITIZER473 mL in 1 BOTTLE, PUMPGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1114LATHER HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]1Legacy NDC, 4 package rows20200722_e15b7e47-739a-45aa-a834-d1268a30b08b.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-111461577-1114-4, 61577-1114-3, 61577-1114-6, 61577-1114-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
ORANGE PEELTI9T76XD44IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
WITCH HAZEL101I4J0U34IACT
ALOE VERA LEAFZY81Z83H0XIACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
FILIPENDULA RUBRA WHOLEMT26BL24AZIACT

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
fb046a9c-a143-47b3-92bc-c1e85f27f115e15b7e47-739a-45aa-a834-d1268a30b08b2020-07-15WarningsExact identifier
spl id: fb046a9c-a143-47b3-92bc-c1e85f27f115
spl set id: e15b7e47-739a-45aa-a834-d1268a30b08b

Reported adverse events (FAERS/openFDA)#

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