FDA.reportPublic FDA data

Oneka Hand Sanitizer Lemon

Manufacturer
Ecoterre Distribution Inc. | Pragmatic Compliance LLC (Corporation)
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:35

Label at a glance#

ProductOneka Hand Sanitizer Lemon
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Antiseptic (skin) cleanser • Antibacterial (skin) cleanser • Kills harmful bacteria and germs • Effective in destroying (harmful) bacteria to provide antiseptic cleansing

Dosage and administration

Adults and children over 2 years • For occasional and personal domestic use • Supervise children when they use this product • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

70% organic ethyl alcohol

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

Uses

INDICATIONS & USAGE SECTION

Antiseptic (skin) cleanser • Antibacterial (skin) cleanser • Kills harmful bacteria and germs • Effective in destroying (harmful) bacteria to provide antiseptic cleansing

WARNINGS

WARNINGS SECTION

For external use only

Flammability Warning Keep away from open flame or sources of heat.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and consult a health care professional

OTC - STOP USE SECTION

if irritation develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years • For occasional and personal domestic use • Supervise children when they use this product • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information:

SPL UNCLASSIFIED SECTION

Store below 35 Cº 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic Aloe Barbadensis (Aloe vera) leaf juice, Organic Salvia officinalis (Sage) extract, Organic Calendula officinalis flower extract, Citrus Limonium (Lemon) essential oil, Salvia officinalis (Sage) essential oil, Glycerin (vegetable).

Questions?

OTC - QUESTIONS SECTION

1-450-524-3737

Package Labeling:4L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleLabelLabel

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81070-100-012023-07-28C16284748780-10191ceaa-6154-198a-e063-dbdaa90aec3eOneka Hand Sanitizer Lemon
81070-100-022023-07-28C16284748780-10191ceaa-6154-198a-e063-dbdaa90aec3eOneka Hand Sanitizer Lemon
81070-100-032023-07-28C16284748780-10191ceaa-6154-198a-e063-dbdaa90aec3eOneka Hand Sanitizer Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81070-100-01Oneka Hand Sanitizer Lemon60 mL in 1 BOTTLELIQUID603
81070-100-02Oneka Hand Sanitizer Lemon500 mL in 1 BOTTLELIQUID5003
81070-100-03Oneka Hand Sanitizer Lemon4000 mL in 1 BOTTLELIQUID40003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81070-100ONEKA HAND SANITIZER LEMON (ALCOHOL) LIQUID [ECOTERRE DISTRIBUTION INC.]3Legacy NDC, 3 package rows20220112_b63507e8-9c65-ed5b-e053-2995a90a9b33.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81070-10081070-100-03, 81070-100-02, 81070-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
SAGE065C5D077JIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LEMON24RS0A988OIACT
SAGE OILU27K0H1H2OIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
d4fffdad-fef1-1993-e053-2a95a90a1ffdb63507e8-9c65-ed5b-e053-2995a90a9b332022-01-07WarningsExact identifier
spl id: d4fffdad-fef1-1993-e053-2a95a90a1ffd
spl set id: b63507e8-9c65-ed5b-e053-2995a90a9b33

Reported adverse events (FAERS/openFDA)#

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