FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Ginesis Natural Products
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:00

Label at a glance#

ProductHand Sanitizer
Active ingredientAlcohol
Label structure10 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

Storage and handling

Store between 15-30° C (59-86°F) Avoid freezing and excessive heat above 40° (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flames.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask doctor if redness or irritation develop. These may be signs of a serious condition.

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 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

STORAGE AND HANDLING SECTION

  • Store between 15-30° C (59-86°F)
  • Avoid freezing and excessive heat above 40° (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

DIST. BY CJH
2501 COUNTY RD 8
WATERLOO, AL 35677

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GINESIS

Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer
Non-Sterile Solution

2 FL OZ. (59 ML)

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

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
79703-080-022022-01-28C16284748780-1d6a99b39-600c-a426-e053-dadaa90af4c2Hand Sanitizer
79703-080-042022-01-28C16284748780-1d6a99b39-600c-a426-e053-dadaa90af4c2Hand Sanitizer
79703-080-082022-01-28C16284748780-1d6a99b39-600c-a426-e053-dadaa90af4c2Hand Sanitizer
79703-080-102022-01-28C16284748780-1d6a99b39-600c-a426-e053-dadaa90af4c2Hand Sanitizer
79703-080-322022-01-28C16284748780-1d6a99b39-600c-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79703-080-02Hand Sanitizer59 mL in 1 BOTTLELIQUID591
79703-080-04Hand Sanitizer118 mL in 1 BOTTLELIQUID1181
79703-080-08Hand Sanitizer237 mL in 1 BOTTLELIQUID2371
79703-080-10Hand Sanitizer3784 mL in 1 BOTTLELIQUID37841
79703-080-32Hand Sanitizer946 mL in 1 BOTTLELIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79703-080HAND SANITIZER (ALCOHOL) LIQUID [GINESIS NATURAL PRODUCTS]1Legacy NDC, 5 package rows20200828_18eda412-4d14-45db-84c9-d6cdad10ee87.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79703-08079703-080-02, 79703-080-04, 79703-080-08, 79703-080-32, 79703-080-10

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
Alcohol3K9958V90MACTIB
glycerinPDC6A3C0OXIACT
hydrogen peroxideBBX060AN9VIACT
water059QF0KO0RIACT

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
1e953021-4ee3-4de0-8b46-e7b3bf81991f18eda412-4d14-45db-84c9-d6cdad10ee872020-08-27WarningsExact identifier
spl id: 1e953021-4ee3-4de0-8b46-e7b3bf81991f
spl set id: 18eda412-4d14-45db-84c9-d6cdad10ee87

Reported adverse events (FAERS/openFDA)#

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