FDA.reportPublic FDA data

Ne Mexico Aging Long Term Services Department Hand Sanitizer

Manufacturer
Sombra Cosmetics
Effective date
2021-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:18

Label at a glance#

ProductNe Mexico Aging Long Term Services Department Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
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 inder 6, use only under adult supervision.

Storage and handling

Store away from oxidizing agents. Do not store above 100 C.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.15%

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.

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.

Stop Use

OTC - STOP USE SECTION

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

Keep out of reach of childrenn

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 inder 6, use only under adult supervision.

Storage and Handling

STORAGE AND HANDLING SECTION

Store away from oxidizing agents. Do not store above 100 C.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, glycerin, cyamopsis tetragonoloba (Guar) gum, citrus limon (lemon) peel oil, hamamelis virginiana (witch hazel) leaf extract, camellia sinensis (green tea) leaf extract, champmilla recutita (matricaria) flower extract, rosa damascena (rose) flower waterr, aloe barbadensis leaf juice, yucca schidigera stem extract, filipendula ulmaria (queen of the prairie) extract, phenoxyethanol, caprylyl glyol, citric acid

Purpose

OTC - PURPOSE SECTION

Anitmicrobial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Mexico Aging and Long Term Services Hand SanitizerNew Mexico Aging and Long Term Services Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2569179benzalkonium chloride 0.15 % Topical GelPSN1
2569179benzalkonium chloride 0.0015 MG/MG Topical GelSCD1
2569179benzalkonium chloride 0.15 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4200-82024-01-30C16284748780-11030e364-fe52-111a-e063-dadaa90a10e2New Mexico Aging Long-Term Services Department Alcohol Free Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4200-8Ne Mexico Aging Long Term Services Department Hand Sanitizer237 g in 1 BOTTLE, PLASTICGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4200NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SOMBRA COSMETICS]1Legacy NDC, 1 package rows20210908_34b0fc65-ca2a-4ac4-bbe3-ccb3d9c0a851.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-420061577-4200-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GUAR GUME89I1637KEIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LEMON OILI9GRO824LLIACT
WITCH HAZEL101I4J0U34IACT
ALOE VERA LEAFZY81Z83H0XIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
CHAMOMILEFGL3685T2XIACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT
FILIPENDULA RUBRA WHOLEMT26BL24AZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
fce28333-43cb-49ac-be61-8b4f811f92ff34b0fc65-ca2a-4ac4-bbe3-ccb3d9c0a8512021-09-03WarningsExact identifier
spl id: fce28333-43cb-49ac-be61-8b4f811f92ff
spl set id: 34b0fc65-ca2a-4ac4-bbe3-ccb3d9c0a851

Reported adverse events (FAERS/openFDA)#

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