FDA.reportPublic FDA data

Sombra Hand Sanitzer

Manufacturer
SOMBRA COSMETICS
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:28

Label at a glance#

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Stop use and ask doctor if, irritation and redness develop condition persists for more than 72 hours.

When using this product

OTC - WHEN USING SECTION

When using this product, 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask doctor if, irritation and redness develop condition persists for 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

Wet hands thoroughly with product and allow to dry without wiping.  For children under 6, use only under adult supervision.  Not recommended for infants.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf juice, Citrus Aurantium Dulce (orange) Peel Oil, Glycerin, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Hamemelis Viginiara Leaf Extract, Yucca Schidigera Root Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902515ethanol 65 % Topical SprayPSN1
902515ethanol 0.65 ML/ML Topical SpraySCD1
902515ethanol 65 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4129-22024-01-30C16284748780-11030e365-495e-111a-e063-dadaa90a10e2Sombra Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4129-2Sombra Hand Sanitzer118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4129SOMBRA HAND SANITZER (ALCOHOL) SPRAY [SOMBRA COSMETICS]1Legacy NDC, 1 package rows20200724_d9dad29c-ab17-4a8a-b222-11e5b79e1c60.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-412961577-4129-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ORANGE PEELTI9T76XD44IACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT

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
9ebfbea5-bbbd-4de0-b41f-71e5a99feae4d9dad29c-ab17-4a8a-b222-11e5b79e1c602020-07-22WarningsExact identifier
spl id: 9ebfbea5-bbbd-4de0-b41f-71e5a99feae4
spl set id: d9dad29c-ab17-4a8a-b222-11e5b79e1c60

Reported adverse events (FAERS/openFDA)#

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