FDA.reportPublic FDA data

KORA Daily Safe 80

Manufacturer
Kora Holdings LLC | Sellus
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:38

Label at a glance#

ProductKORA Daily Safe 80
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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

Storage and handling

Store below 110°F (43°C)

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 World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold 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 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended for repeated use.

Use

RECENT MAJOR CHANGES SECTION

-Put enough product in your palm to cover hands and rub hands together briskly until dry.

-Children under 6 years of age should be supervised when using.

Warnings

WARNINGS SECTION

For external use on hands only. Flammable. Keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, swelling or redness develops.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, swelling or redness develops.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin (Glycerol), hydrogen peroxide, Sterile Distilled Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 75504-080-01 80 gel label_500ml80 gel label_500ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75504-180-112022-01-28C16284748780-1d6a99b3a-007e-a426-e053-dadaa90af4c2a375f052-b638-33d3-e053-2a95a90a5aaa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75504-180-11KORA Daily Safe 80500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75504-180KORA DAILY SAFE 80 (HAND SANITIZER GEL) GEL [KORA HOLDINGS LLC]2Legacy NDC, 1 package rows20201221_a375f052-b638-33d3-e053-2a95a90a5aaa.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75504-18075504-180-11

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
b68ae824-2a9e-1244-e053-2995a90aaf22a375f052-b638-33d3-e053-2a95a90a5aaa2020-12-15WarningsExact identifier
spl id: b68ae824-2a9e-1244-e053-2995a90aaf22
spl set id: a375f052-b638-33d3-e053-2a95a90a5aaa

Reported adverse events (FAERS/openFDA)#

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