FDA.reportPublic FDA data

DISINFEX

Manufacturer
RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:21:33

Label at a glance#

ProductDISINFEX
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

to help reduce bacteria on the skin. For use when soap and water are not avaliable.

Dosage and administration

Put enough product in your palm to cover hands and rub hands together until dry. Children under 6 years should be supervised when using this product.

Storage and handling

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F) may discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.5% v/v).
  3. Aloe Vera Leaf (0.1% v/v).
  4. Carbomer 940 (0.3% v/v).
  5. Aminomethylpropanol (0.15% v/v).
  6. Sterile distilled water

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Disinfex Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on the skin. For use when soap and water are not avaliable.

Warnings

WARNINGS SECTION

For external use only. Flammable liquid and vapor. Keep away from heat/sparks/open flame. No smoking. Avoid sprayin in eyes.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness devolops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)
  • may discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethylpropanol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1L NDC: 79320-120-05 1 L label1 L label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79320-120-052022-01-28C16284748780-1d6a99b39-c41b-a426-e053-dadaa90af4c2a972285e-3524-22d9-e053-2a95a90a22e6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79320-120-05DISINFEX1000 mL in 1 BOTTLEGEL10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79320-120DISINFEX (ALCOHOL) GEL [RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI]5Legacy NDC, 1 package rows20200716_a972285e-3524-22d9-e053-2a95a90a22e6.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
79320-12079320-120-05

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
aa7d2655-c3a5-59f8-e053-2a95a90a25e3a972285e-3524-22d9-e053-2a95a90a22e62020-07-15WarningsExact identifier
spl id: aa7d2655-c3a5-59f8-e053-2a95a90a25e3
spl set id: a972285e-3524-22d9-e053-2a95a90a22e6

Reported adverse events (FAERS/openFDA)#

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