FDA.reportPublic FDA data

SOMBRA ANTIBACTERIAL HAND SANITIZER

Manufacturer
SOMBRA COSMETICS
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:56

Label at a glance#

ProductSOMBRA ANTIBACTERIAL 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.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Storage and handling

Do not store above 105 F.  May discolor some fabrics and may harm wood finishes.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

avoid contact with broken skin. Do not inhale or ingest.  Children under 6, use only
under adult supervision.  Not recommended for infants.

When Using

OTC - WHEN USING SECTION

When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.

OTC - STOP USE SECTION

Stop use if irritation and redness develop or if condition persists for more than 72 hours.

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

Wet hands thoroughly with product and allow to dry without wiping.

Storage and Handling

STORAGE AND HANDLING SECTION

Do not store above 105 F.  May discolor some fabrics and may harm wood finishes.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water, isopropyl alcohol, aminomethyl propanol, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract,  rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.

Purpose

OTC - PURPOSE SECTION

Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sombra Economy Hand SanitizerSombra Economy Hand Sanitizer

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130763669002081GTIN-13: 0763669002081
EAN-13: 0763669002081
GTIN-12: 763669002081
UPC-A: 763669002081
GTIN storage (14 digits): 00763669002081		Sombra8ozeconomy.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4130-12024-01-30C16284748780-11030e365-46b0-111a-e063-dadaa90a10e2Sombra Antibacterial Hand Sanitizer
61577-4130-62024-01-30C16284748780-11030e365-46b0-111a-e063-dadaa90a10e2Sombra Antibacterial Hand Sanitizer
61577-4130-82024-01-30C16284748780-11030e365-46b0-111a-e063-dadaa90a10e2Sombra Antibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4130-1SOMBRA ANTIBACTERIAL HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICGEL37851
61577-4130-6SOMBRA ANTIBACTERIAL HAND SANITIZER473 mL in 1 BOTTLE, PUMPGEL4731
61577-4130-8SOMBRA ANTIBACTERIAL HAND SANITIZER237 mL in 1 BOTTLE, PUMPGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4130SOMBRA ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]1Legacy NDC, 3 package rows20200729_6c911e60-f111-4476-8235-f4f205521bf7.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-413061577-4130-1, 61577-4130-6, 61577-4130-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LEMON PEEL72O054U628IACT
ORANGE OILAKN3KSD11BIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
89b1fda5-ca8b-4955-9a79-369cccd9f8776c911e60-f111-4476-8235-f4f205521bf72020-07-29WarningsExact identifier
spl id: 89b1fda5-ca8b-4955-9a79-369cccd9f877
spl set id: 6c911e60-f111-4476-8235-f4f205521bf7

Reported adverse events (FAERS/openFDA)#

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