FDA.reportPublic FDA data

Omni Fresh by Facela Hand Sanitizer Gel

Manufacturer
Industrias Facela SA de CV
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:46:46

Label at a glance#

ProductOmni Fresh by Facela Hand Sanitizer
Active ingredientALCOHOL
Label structure6 sections

Indications and uses

Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available.

Dosage and administration

Read the entire label before using this product. Dispense 2 pumps of produc onto palm of hand and rub thoroughly over all surfaces of both hands until dry.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • Hand sanitizer to reduce microorganisms on the skin.
  • Use this product when soap and water are not available.

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Flammable. This product contains ethyl alcohol. Keep away from source of ignition.
  • Discontinue use if irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Read the entire label before using this product.
  • Dispense 2 pumps of produc onto palm of hand and rub thoroughly over all surfaces of both hands until dry.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Fragrance

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78587-00078587-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EDETOLQ4R969U9FRIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
28efaffe-9ae1-5bc7-e063-6394a90a1352e9f08289-8e27-4055-ad7c-84f3ed8a2b202024-12-10WarningsExact identifier
spl id: 28efaffe-9ae1-5bc7-e063-6394a90a1352
spl set id: e9f08289-8e27-4055-ad7c-84f3ed8a2b20

Reported adverse events (FAERS/openFDA)#

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