FDA.reportPublic FDA data

Exmicror

Manufacturer
Biorganicos Robech, S. de R.L. de C.V.
Effective date
2024-02-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:11:31

Label at a glance#

ProductExmicror
Active ingredientBENZALKONIUM CHLORIDE
Label structure17 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 avoid swallowing.

Storage and handling

Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • 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 avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ascorbic acid, citric acid, glycerin USP, purified water USP.

EXMICROR 60ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 60ml - Hand Sanitizer NDC:77733-002-04 Exmicror_60mlExmicror_60ml

EXMICROR 125ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 125ml - Hand Sanitizer NDC:77733-002-05 Exmicror_125mlExmicror_125ml

EXMICROR 250ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 250ml - Hand Sanitizer NDC:77733-002-06 Exmicror_250mlExmicror_250ml

EXMICROR 500ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 500ml - Hand Sanitizer NDC:77733-002-07 Exmicror_500mlExmicror_500ml

EXMICROR 1000ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 1000ml - Hand Sanitizer NDC:77733-002-03 Exmicror_1lExmicror_1l

EXMICROR 5000ml - HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exmicror 5000ml - Hand Sanitizer NDC:77733-002-08 Exmicror_5lExmicror_5l

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77733-002-032024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-042024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-052024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-062024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-072024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-082024-02-13C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-032024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-042024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-052024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-062024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-072024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )
77733-002-082024-01-30C16284748780-11030e365-3852-111a-e063-dadaa90a10e2Hand Sanitizer 1L (with citric acid and ascorbic acid )

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
77733-00277733-002-03, 77733-002-04, 77733-002-05, 77733-002-06, 77733-002-07, 77733-002-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
WATER059QF0KO0RIACT

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
249bcbd2-b236-df3e-e063-6294a90ada71b1b808ba-0faa-8f8b-e053-2995a90a4f002024-10-16WarningsExact identifier
spl set id: b1b808ba-0faa-8f8b-e053-2995a90a4f00

Reported adverse events (FAERS/openFDA)#

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