FDA.reportPublic FDA data

ELLEN HAND SANITIZER2

Manufacturer
PT. SUPER HOME PRODUCT INDONESIA
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:25

Label at a glance#

ProductELLEN HAND SANITIZER2
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Place enough product on hands to cover all surfaces.Rub hands together until dry. Supervise children under 6 years of age when using this product to avoidswalowing.Not recommended for infants.

Label contents#

Full prescribing information#

USE

DOSAGE & ADMINISTRATION SECTION

Use Hand sanitizer to help reduce bacteria that potentially can cause diseaseFor use when soap and water are not ava'lable.

Warnings

WARNINGS SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Fragrance, Aloe Extract,Glycerin, CarbomerTocopherylAcetate,Aminomethyl Propanol.

Directions

INDICATIONS & USAGE SECTION

  • Place enough product on hands to cover all surfaces.Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoidswalowing.Not recommended for infants.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact a PoisonControlCenter right away.

Purpose

OTC - PURPOSE SECTION

Antimicrobial，Hand Sanitizer

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 60%v/v Purpose：Antimicrobial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367692ethanol 60 % Topical SprayPSN1
1367692ethanol 0.6 ML/ML Topical SpraySCD1
1367692ethanol 60 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85537-102-02ELLEN HAND SANITIZER245 mL in 1 BOTTLE, SPRAYSPRAY451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85537-102ELLEN HAND SANITIZER2 (ETHYL ALCOHOL) SPRAY [PT. SUPER HOME PRODUCT INDONESIA]1Current NDC, 1 package rows20250422_334574b6-6d4a-bd37-e063-6394a90a67d6.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
85537-10285537-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER0A5MM307FCIACT
AQUA059QF0KO0RIACT
ALOEV5VD430YW9IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
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
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
ndc (package): 85537-102-02
ndc (product): 85537-102
ndc11 (package): 85537010202
spl id: 334574b6-6d4b-bd37-e063-6394a90a67d6
spl set id: 334574b6-6d4a-bd37-e063-6394a90a67d6

Reported adverse events (FAERS/openFDA)#

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