Germisept Anti-Bacterial Alcohol Hand sanitizer Gel

Manufacturer
Alpha Hygiene LLC
Effective date
2020-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:43

Label at a glance#

ProductGermisept Antibacterial Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to decrease bacteria on the skin that could cause disease. recommended for repeated use.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.  Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease.
  • recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only. 
  • Flammable.
  • Keep away from heat or flame.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.
  • In case of contact with eyes, flush throughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develops
  • condition persists for more than 72 hours.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry. 
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

SPL UNCLASSIFIED SECTION

  • Do not store above 105°F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycerin, Acrylates/c10-30 alkyl acrylate crosspolymer, Aminomethyl propanol, Fragrance (Perfume).

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:3800ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80862-000-01Germisept Antibacterial Alcohol Hand Sanitizer1000 mL in 1 POUCHGEL10001
80862-000-02Germisept Antibacterial Alcohol Hand Sanitizer3800 mL in 1 CANGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80862-000GERMISEPT ANTIBACTERIAL ALCOHOL HAND SANITIZER (ALCOHOL) GEL [ALPHA HYGIENE LLC]1Legacy NDC, 2 package rows20201101_b2a7bafc-4c0e-e927-e053-2a95a90a9234.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
80862-00080862-000-01, 80862-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
b2a7bafc-4c0f-e927-e053-2a95a90a9234b2a7bafc-4c0e-e927-e053-2a95a90a92342020-10-27WarningsExact identifier
spl id: b2a7bafc-4c0f-e927-e053-2a95a90a9234
spl set id: b2a7bafc-4c0e-e927-e053-2a95a90a9234

Reported adverse events (FAERS/openFDA)#

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