FDA.reportPublic FDA data

PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER

Manufacturer
SOMBRA COSMETICS
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:19

Label at a glance#

ProductPURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria and viruses on the skin that could cause disease

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

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 this product

OTC - WHEN USING SECTION

Keept out of the eyes.  In case of contact with eyes, flush shoroughly with water.  Avoid contact with broke skin.  Do not inhale or ingest.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.  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 Extract, Aminomethyl Propanol, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel
Oil, Citrus Limon (Lemon) Peel Oil, Filipendula Ulmaria, (Queen of the Prairie) Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Yucca Schidigera Stem Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1118-42024-01-30C16284748780-11030e365-4e6b-111a-e063-dadaa90a10e2PURE & ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER
61577-1118-62024-01-30C16284748780-11030e365-4e6b-111a-e063-dadaa90a10e2PURE & ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER
61577-1118-82024-01-30C16284748780-11030e365-4e6b-111a-e063-dadaa90a10e2PURE & ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1118-4PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER118 mL in 1 BOTTLE, PLASTICGEL1182
61577-1118-6PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER474 mL in 1 BOTTLE, PLASTICGEL4742
61577-1118-8PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER237 mL in 1 BOTTLE, PLASTICGEL2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1118PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]2Legacy NDC, 3 package rows20200723_b322f9a2-7bdd-4acd-a3e0-527cc07ba6bb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-111861577-1118-8, 61577-1118-4, 61577-1118-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
ORANGE PEELTI9T76XD44IACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT

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
6a955818-0497-47b8-af66-4f56b9608a68b322f9a2-7bdd-4acd-a3e0-527cc07ba6bb2020-07-16WarningsExact identifier
spl id: 6a955818-0497-47b8-af66-4f56b9608a68
spl set id: b322f9a2-7bdd-4acd-a3e0-527cc07ba6bb

Reported adverse events (FAERS/openFDA)#

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