FDA.reportPublic FDA data

Trademark Hand Sanitizer

Manufacturer
Organikisimo, S.A. de C:V.
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:59

Label at a glance#

ProductTrademark Hand Sanitizer
Active ingredientALCOHOL
Label structure14 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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

Warnings

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

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.


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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin,Triethanolamine, Tocopheryl Acetate (Vitamin E).

Package Label - TRADEMARK 59 ml NDC:79337-172-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml NDC:79337-172-01

TRADEMARK_59mlTRADEMARK_59ml

Package Label - TRADEMARK 250 ml NDC:79337-172-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 ml NDC: 79337-172-02

TRADEMARK_250mlTRADEMARK_250ml

Package Label - TRADEMARK 1000 ml NDC:79337-172-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ml NDC: 79337-172-03

TRADEMARK_1000mlTRADEMARK_1000ml

Package Label - TRADEMARK 3785 ml NDC: 79337-172-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 ml NDC: 79337-172-04

TRADEMARK_3700mlTRADEMARK_3700ml

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
79337-172-012022-01-28C16284748780-1d6a99b39-b348-a426-e053-dadaa90af4c2TRADEMARK HAND SANITIZER Alcohol 70%
79337-172-022022-01-28C16284748780-1d6a99b39-b348-a426-e053-dadaa90af4c2TRADEMARK HAND SANITIZER Alcohol 70%
79337-172-032022-01-28C16284748780-1d6a99b39-b348-a426-e053-dadaa90af4c2TRADEMARK HAND SANITIZER Alcohol 70%
79337-172-042022-01-28C16284748780-1d6a99b39-b348-a426-e053-dadaa90af4c2TRADEMARK HAND SANITIZER Alcohol 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79337-172-01Trademark Hand Sanitizer59 mL in 1 BOTTLEGEL591
79337-172-02Trademark Hand Sanitizer250 mL in 1 BOTTLEGEL2501
79337-172-03Trademark Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79337-172-04Trademark Hand Sanitizer3785 mL in 1 CONTAINERGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79337-172TRADEMARK HAND SANITIZER (ALCOHOL) GEL [ORGANIKISIMO, S.A. DE C:V.]1Legacy NDC, 4 package rows20201120_b47a6112-77d2-12cd-e053-2a95a90a812d.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
79337-17279337-172-01, 79337-172-02, 79337-172-03, 79337-172-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
b47a6112-77d4-12cd-e053-2a95a90a812db47a6112-77d2-12cd-e053-2a95a90a812d2020-11-19WarningsExact identifier
spl id: b47a6112-77d4-12cd-e053-2a95a90a812d
spl set id: b47a6112-77d2-12cd-e053-2a95a90a812d

Reported adverse events (FAERS/openFDA)#

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