FDA.reportPublic FDA data

Arabsabio Hand Sanitizer

Manufacturer
Multiplex Bio-tech Private Limited
Effective date
2023-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:15

Label at a glance#

ProductShuddi Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Hand & Skin Antiseptic

INDICATIONS & USAGE SECTION

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Avoid contact with eyes.

If eye contact occurs, rinse throughly with water.

OTC - ASK DOCTOR SECTION

If irritation or redness develops or persists for 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children should be supervised when using this product

DOSAGE & ADMINISTRATION SECTION

Apply 5 to 6 drops each use to clearn and protect hands

Work thoroughly onto hands and allow it to dry without wiping

Reapply as needed. Rpeat application increases effectiveness.

INACTIVE INGREDIENT SECTION

Glycerin, Vitamin E, Proprietary blend of Metabolites, Deionized water.

OTC - QUESTIONS SECTION

Call customer care cell: 080-2349-3692

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multiplex

Shuddi Antiseptic Disinfectant Hand Sanitizer

Kills 99.9% of Germs and Bacteria on Hands

Alcohol Free Bio-Organic

Multiplex Shuddi Hand sanitizer is a bio-organic product useful in sanitization and disinfection.

Key Features:

* Alcohol free liquid for hand sanitization & hand disinfection, having antimicrobial & germicidal property.

* Moisturizes using Glycerin and Vitamin E. non-combustible, non-staining, dye-free formula.

* Specially formulated blend of ingredients is safe on skin but tough on germs.

Manufactured by

Multiplex Bio-Tech Pvt. Ltd

No. 180, 1st Main Road, Mahalakshmi Layout Extension,

Bengaluru- 560 086. India

Ph.: 080-2349 7464, 2349 4406, 2349 7360

Email: shuddi-blr@multiplexgroup.com

Website: www.shuddi.com

Good Manufacturing Practice (GMP)

Xx fl oz (XX mL) NDC: 81105-001-XX; 81105-002-XX

Arabsabio-20mLArabsabio-20mL

Arabsabio-100mLArabsabio-100mL

Arabsabio-250mLArabsabio-250mL

Arabsabio-500mLArabsabio-500mL

Arabsabio-5LArabsabio-5L

Shuddi-20 mLShuddi-20 mL

Shuddi-100 mLShuddi-100 mL

Shuddi-250 mLShuddi-250 mL

Shuddi-500 mLShuddi-500 mL

Shuddi-5 LiterShuddi-5 Liter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81105-001-012024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-022024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-052024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-252024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-502024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-012024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-022024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-052024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-252024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-502024-07-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-012024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-022024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-052024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-252024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-001-502024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-012024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-022024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-052024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-252024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts
81105-002-502024-01-30C16284748780-11030e365-67be-111a-e063-dadaa90a10e2Drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81105-001-01Shuddi Hand Sanitizer100 mL in 1 BOTTLELIQUID1002
81105-001-02Shuddi Hand Sanitizer20 mL in 1 BOTTLELIQUID202
81105-001-05Shuddi Hand Sanitizer500 mL in 1 BOTTLELIQUID5002
81105-001-25Shuddi Hand Sanitizer250 mL in 1 BOTTLELIQUID2502
81105-001-50Shuddi Hand Sanitizer5000 mL in 1 CANLIQUID50002
81105-002-01Arabsabio Hand Sanitizer100 mL in 1 BOTTLELIQUID1002
81105-002-02Arabsabio Hand Sanitizer20 mL in 1 BOTTLELIQUID202
81105-002-05Arabsabio Hand Sanitizer500 mL in 1 BOTTLELIQUID5002
81105-002-25Arabsabio Hand Sanitizer250 mL in 1 BOTTLELIQUID2502
81105-002-50Arabsabio Hand Sanitizer5000 mL in 1 CANLIQUID50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81105-001SHUDDI HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID ARABSABIO HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [MULTIPLEX BIO-TECH PRIVATE LIMITED]2Legacy NDC, 5 package rows20230115_bbd0772b-b464-43a6-e053-2a95a90a7ffc.zip
81105-002SHUDDI HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID ARABSABIO HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [MULTIPLEX BIO-TECH PRIVATE LIMITED]2Legacy NDC, 5 package rows20230115_bbd0772b-b464-43a6-e053-2a95a90a7ffc.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81105-00181105-001-50, 81105-001-05, 81105-001-25, 81105-001-01, 81105-001-02
81105-00281105-002-50, 81105-002-05, 81105-002-25, 81105-002-01, 81105-002-02

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
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
f22821d1-a344-21a0-e053-2a95a90a483abbd0772b-b464-43a6-e053-2a95a90a7ffc2023-01-13WarningsExact identifier
spl id: f22821d1-a344-21a0-e053-2a95a90a483a
spl set id: bbd0772b-b464-43a6-e053-2a95a90a7ffc

Reported adverse events (FAERS/openFDA)#

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