FDA.reportPublic FDA data

80% Gel Hand Sanitizer

Manufacturer
CBIO Brand Distribution International Inc.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:07

Label at a glance#

Product80% Gel Hand Sanitizer
Active ingredientALCOHOL
Label structure11 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Gel 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 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), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Section 3: Use (06/2020) Section 8: Directions (06/2020)

RECENT MAJOR CHANGES SECTION

Section 3:

To help reduce bacteria on skin. (06/2020)

Section 8:

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product. (06/2020)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SGX80 Gel 60 mLSGX80 Gel 60 mLSGX80 Gel 100 mLSGX80 Gel 100 mLSGX80 Gel 250 mLSGX80 Gel 250 mLSGX80 Gel 500 mLSGX80 Gel 500 mLSGX80 Gel 1 GallonSGX80 Gel 1 GallonSGX80 Gel 55 GallonSGX80 Gel 55 GallonSGX80 Gel 265 GallonSGX80 Gel 265 Gallon60 mL NDC: 78044-200-07

100 mL NDC: 78044-200-01

250 mL NDC: 78044-200-02

500 mL NDC: 78044-200-03

3.785 L NDC: 78044-200-04

208.198 L NDC: 78044-200-05

1003.13 L NDC: 78044-200-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78044-200-012022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-022022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-032022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-042022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-052022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-062022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer
78044-200-072022-01-28C16284748780-1d6a99b39-5aad-a426-e053-dadaa90af4c2Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78044-200-0180% Gel Hand Sanitizer100 mL in 1 TUBEGEL1001
78044-200-0280% Gel Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78044-200-0380% Gel Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78044-200-0480% Gel Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
78044-200-0580% Gel Hand Sanitizer208198 mL in 1 DRUMGEL2081981
78044-200-0680% Gel Hand Sanitizer1003130 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10031301
78044-200-0780% Gel Hand Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78044-20080% GEL HAND SANITIZER (ALCOHOL) GEL [CBIO BRAND DISTRIBUTION INTERNATIONAL INC.]1Legacy NDC, 7 package rows20200611_a7b25805-0466-6dc0-e053-2a95a90a0ed4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78044-20078044-200-01, 78044-200-02, 78044-200-03, 78044-200-04, 78044-200-05, 78044-200-06, 78044-200-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
RAPIDGEL EZ133JH4A7R2KIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SQUALANEGW89575KF9IACT
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
a7b23795-bbfd-250c-e053-2995a90abb0ba7b25805-0466-6dc0-e053-2a95a90a0ed42020-06-09WarningsExact identifier
spl id: a7b23795-bbfd-250c-e053-2995a90abb0b
spl set id: a7b25805-0466-6dc0-e053-2a95a90a0ed4

Reported adverse events (FAERS/openFDA)#

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