Luvone Antibacterial Sanitizer Gel

Manufacturer
INDUSTRIAS MC CLEAN S A S
Effective date
2020-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:19

Label at a glance#

ProductLuvone Antibacterial Sanitizer
Active ingredientALCOHOL
Label structure7 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70 % 

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

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

Warning(s)

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age.
  • On open skin wounds.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Fragrance (Parfum),Carbomer,Glycerin, Propylene Glycol, Triethanolamine, and Tocopheryl Acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80683-000-012023-01-30C16284748780-1f386c64a-0087-0266-e053-dadaa90a7c1aLuvone Antibacterial Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80683-000-01Luvone Antibacterial Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80683-000LUVONE ANTIBACTERIAL SANITIZER (ALCOHOL) GEL [INDUSTRIAS MC CLEAN S A S]1Legacy NDC, 1 package rows20210101_b25730b8-02a3-9b50-e053-2995a90a6be0.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
80683-00080683-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
b25730b8-02a4-9b50-e053-2995a90a6be0b25730b8-02a3-9b50-e053-2995a90a6be02020-10-23WarningsExact identifier
spl id: b25730b8-02a4-9b50-e053-2995a90a6be0
spl set id: b25730b8-02a3-9b50-e053-2995a90a6be0

Reported adverse events (FAERS/openFDA)#

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