FDA.reportPublic FDA data

Sanigenix Liquid Hand Sanitizer

Manufacturer
CBIO Brand Distribution International Inc.
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:04

Label at a glance#

ProductSanigenix Liquid Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

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. Hydrogen peroxide (0.125% v/v).
  3. 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

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on skin.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from source of heat & fire.

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 & ask doctor if irritation or rash occurs or redness develops & persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau), Hydrogen Peroxide

RECENT MAJOR CHANGES SECTION

Section 4:

To help reduce bacteria on skin.

Section 9:

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry.

Children under 5 should be supervised using this product.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SGX80 Liquid 265 GallonSGX80 Liquid 265 GallonSGX80 Liquid 55 GallonSGX80 Liquid 55 GallonSGX80 Liquid 1 GallonSGX80 Liquid 1 Gallon1 GALLON (3.785L) NDC: 78044-300-04

55 GALLON (208.198L) NDC: 78044-300-05

265 GALLON (1003.13L) NDC: 78044-300-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78044-300-042022-01-28C16284748780-1d6a99b39-dc36-a426-e053-dadaa90af4c280% Liquid Hand Sanitizer
78044-300-052022-01-28C16284748780-1d6a99b39-dc36-a426-e053-dadaa90af4c280% Liquid Hand Sanitizer
78044-300-062022-01-28C16284748780-1d6a99b39-dc36-a426-e053-dadaa90af4c280% Liquid Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78044-300-04Sanigenix Liquid Hand Sanitizer3785 mL in 1 BOTTLELIQUID37852
78044-300-05Sanigenix Liquid Hand Sanitizer208198 mL in 1 DRUMLIQUID2081982
78044-300-06Sanigenix Liquid Hand Sanitizer1003130 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID10031302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78044-300SANIGENIX LIQUID HAND SANITIZER (ALCOHOL) LIQUID [CBIO BRAND DISTRIBUTION INTERNATIONAL INC.]2Legacy NDC, 3 package rows20200611_a6ae8fc2-0e3a-75f3-e053-2995a90a2f49.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78044-30078044-300-05, 78044-300-04, 78044-300-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
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
a7c8f11f-1935-5eea-e053-2995a90abb23a6ae8fc2-0e3a-75f3-e053-2995a90a2f492020-06-11WarningsExact identifier
spl id: a7c8f11f-1935-5eea-e053-2995a90abb23
spl set id: a6ae8fc2-0e3a-75f3-e053-2995a90a2f49

Reported adverse events (FAERS/openFDA)#

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