FDA.reportPublic FDA data

SHOFF HAND SANITIZER

Manufacturer
HIMMELGEISTER INC. dba HBA Global
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:00

Label at a glance#

ProductSHOFF HAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin

Dosage and administration

Wet your hands thoroughly with the SHOFF Hand Sanitizer, rub until dry without wiping. For children under6, use ONLY under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% V/V

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, PARFUM, Tocopheryl Acetate(Vitamin E)

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Wet your hands thoroughly with the SHOFF Hand Sanitizer, rub until dry without wiping.
  • For children under6, use ONLY under adult supervision.
  • Not recommended for infants.

Warnings:

WARNINGS SECTION

  • For external use only: hands
  • Flammable, keep away from fire or flame
  • Keep out of reach of children
  • Do not store above 100F(38C)
  • May discolor fabrics
  • Harmful to wood finishes and plastics

When using this product:

  • Keep out of eyes
  • In Case of contact of eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Distributed by:

HBA Global.

Eastvale, CA 92880

Made in China

Item#: YZ669

860004093701

Quick-Antibacterial-Disinfection

KILLS MOST COMMON GERMS

MOISTURIZING

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78021-370-012022-01-28C16284748780-1d6a99b39-a85a-a426-e053-dadaa90af4c2SHOff Original HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78021-370-01SHOFF HAND SANITIZER500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78021-370SHOFF HAND SANITIZER (ETHYL ALCOHOL) GEL [HIMMELGEISTER INC. DBA HBA GLOBAL]1Legacy NDC, 1 package rows20200605_0e4ef8e8-d019-48e1-8d60-26790a3de7bc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78021-37078021-370-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
4947fb09-adc7-4709-9afe-87509785418e0e4ef8e8-d019-48e1-8d60-26790a3de7bc2020-05-29WarningsExact identifier
spl id: 4947fb09-adc7-4709-9afe-87509785418e
spl set id: 0e4ef8e8-d019-48e1-8d60-26790a3de7bc

Reported adverse events (FAERS/openFDA)#

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