FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Exelencia Importers, Corp. | Biocosmetica Exel Argentina SRL
Effective date
2024-06-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:48

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Decreases bacteria on skin that pontetially can cause disease Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry. Children under 6 years of age, use only under adult supervision.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Decreases bacteria on skin that pontetially can cause disease

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame

When using this product, avoid contact with eyes, ears and mouth. In case of contact with eyes flush thoroughly with water.

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, avoid contact with eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water.

Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if redness or irritation develops & persits 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

  • Wet hands thoroughly with product and allow to dry.
  • Children under 6 years of age, use only under adult supervision.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Carbomer, Triethanolamine, Fragrance (Parfum), Phospholipids, Polyquaternium-16, BHT, Panthenol, Niacinamide, Dimethicone, Bisabolol, Phenoxyethanol, Tocopheryl Acetate, CI 16035

Fromsoybean lecithin. FD&C RED 40.

Other Information

OTHER SAFETY INFORMATION

Do not store above 105F (43C).

May discolor some fabrics and surfaces.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXEL

ALCOHOL EN GEL ANTIMICROBIANO

con liposomas humectantes y suavizantes

ALCOOL GEL ANTIMICROBIANO

com lipossomas de acao humectante e suavizante

HAND SANITIZER

with moisturizing and softening liposomes

BIOCOSMETICA PROFESIONAL

1.69 fl. Oz/50 ml e

USA-490-TODOS-0720USA-490-TODOS-0720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53863-002-012023-04-12C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-022023-04-12C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-032023-04-12C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-042023-04-12C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-052023-04-12C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-012023-01-30C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-022023-01-30C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-032023-01-30C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-042023-01-30C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER
53863-002-052023-01-30C16284748780-1f386c64a-33f7-0266-e053-dadaa90a7c1aHAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-002-01Hand Sanitizer50 mL in 1 BOTTLEGEL504
53863-002-02Hand Sanitizer200 mL in 1 BOTTLEGEL2004
53863-002-03Hand Sanitizer250 mL in 1 BOTTLEGEL2504
53863-002-04Hand Sanitizer475 mL in 1 BOTTLEGEL4754
53863-002-05Hand Sanitizer4000 mL in 1 BOTTLEGEL40004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-002HAND SANITIZER (ETHYL ALCOHOL) GEL [EXELENCIA IMPORTERS, CORP.]4Current NDC, Legacy NDC, 5 package rows20240708_abffec96-20e5-fd78-e053-2a95a90a4b08.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53863-00253863-002-01, 53863-002-02, 53863-002-03, 53863-002-04, 53863-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5))1KX12A42IJIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PANTHENOLWV9CM0O67ZIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 40WZB9127XOAIACT
NIACINAMIDE25X51I8RD4IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
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
Hand SanitizerETHYL ALCOHOLExelencia Importers, Corp.abffec96-20e5-fd78-e053-2a95a90a4b082024-06-30WarningsExact identifier
ndc (package): 53863-002-05
ndc (package): 53863-002-02
ndc (package): 53863-002-04
ndc (package): 53863-002-01
ndc (package): 53863-002-03
ndc (product): 53863-002
ndc11 (package): 53863000203
ndc11 (package): 53863000201
ndc11 (package): 53863000205
ndc11 (package): 53863000202
ndc11 (package): 53863000204
spl id: 1c250982-7ac2-a037-e063-6294a90ad6f6
spl set id: abffec96-20e5-fd78-e053-2a95a90a4b08

Reported adverse events (FAERS/openFDA)#

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