XEPI Rub ET HAND SANITIZING HANDRUB

Manufacturer
Sanmed Healthcare Private Limited
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:24

Label at a glance#

ProductXEPI Rub ET HAND SANITIZING HANDRUB
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

* A hand rub to decrease microbial load on the skin

Dosage and administration

* Apply product onto hands, spread thoroughly & rub until dry.

Storage and handling

* Store below 30°C * See Safety Data Sheet (SDS) * For emergency medical information in USA, call ..........................

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80.0% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic Handrub

Uses:

INDICATIONS & USAGE SECTION

* A hand rub to decrease microbial load on the skin

Warnings:

WARNINGS SECTION

* For external use only

* Flammable. Keep away from fire or flame, heat sparks and sources of static discharge.

When using this product:

* Keep out of Eyes, Ears and Mouth.

* In case of contact with eyes, rinse promptly & thoroughly with water.

* Discontinue use if irritation and redness develop.

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

* Apply product onto hands, spread thoroughly & rub until dry.

Other information:

STORAGE AND HANDLING SECTION

* Store below 30°C

* See Safety Data Sheet (SDS)

* For emergency medical information in USA, call ..........................

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Hydrogen Peroxide 0.125% v/v, Water (aqua), Glycerin, Carbomer 940, Aminomethyl Propanol, Dettol Frag.

Questions or comments?

OTC - QUESTIONS SECTION

* Call: +91 40 4221 2432 / 33

* Email: info@sanmed.in

SPL UNCLASSIFIED SECTION

World Health Organization Recommended Formulation

Manufactured by:

Sanmed Healthcare Pvt. Ltd.

Plot No: 56, TSIIC, Biotech Park Phase-III

Karakapatla - 502279. India.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XepirubXepirub

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81357-101-01XEPI Rub ET HAND SANITIZING HANDRUB60 mL in 1 BOTTLESOLUTION601
81357-101-02XEPI Rub ET HAND SANITIZING HANDRUB100 mL in 1 BOTTLESOLUTION1001
81357-101-03XEPI Rub ET HAND SANITIZING HANDRUB240 mL in 1 BOTTLESOLUTION2401
81357-101-04XEPI Rub ET HAND SANITIZING HANDRUB500 mL in 1 BOTTLESOLUTION5001
81357-101-05XEPI Rub ET HAND SANITIZING HANDRUB1000 mL in 1 BOTTLESOLUTION10001
81357-101-06XEPI Rub ET HAND SANITIZING HANDRUB3785 mL in 1 BOTTLESOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81357-101XEPI RUB ET HAND SANITIZING HANDRUB (ETHYL ALCOHOL) SOLUTION [SANMED HEALTHCARE PRIVATE LIMITED]1Legacy NDC, 6 package rows20210105_59373081-da0d-4495-ae20-1fe7264fe68a.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
81357-10181357-101-01, 81357-101-02, 81357-101-03, 81357-101-04, 81357-101-05, 81357-101-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
1a2a7344-81e5-44a0-b294-7181c56bb01b59373081-da0d-4495-ae20-1fe7264fe68a2020-12-28WarningsExact identifier
spl id: 1a2a7344-81e5-44a0-b294-7181c56bb01b
spl set id: 59373081-da0d-4495-ae20-1fe7264fe68a

Reported adverse events (FAERS/openFDA)#

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