FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Gemini Industries Inc.
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:21

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Use as hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. 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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water USP, hydroxyethylcellulose

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3780 mL NDC: 74100-002-01 3780mL3780mL

18930 mL NDC: 74100-002-05 18930mL18930mL

208197648 mL NDC: 74100-002-55 208197648mL208197648mL

124918530 mL NDC: 74100-002-33 124918530mL124918530mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74100-002-012022-01-28C16284748780-1d6a99b39-715e-a426-e053-dadaa90af4c2a4e97b02-e92c-b0a3-e053-2a95a90a3192
74100-002-052022-01-28C16284748780-1d6a99b39-715e-a426-e053-dadaa90af4c2a4e97b02-e92c-b0a3-e053-2a95a90a3192
74100-002-332022-01-28C16284748780-1d6a99b39-715e-a426-e053-dadaa90af4c2a4e97b02-e92c-b0a3-e053-2a95a90a3192
74100-002-552022-01-28C16284748780-1d6a99b39-715e-a426-e053-dadaa90af4c2a4e97b02-e92c-b0a3-e053-2a95a90a3192

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74100-002-01Hand Sanitizer3780 mL in 1 JUGGEL37801
74100-002-05Hand Sanitizer18930 mL in 1 JUGGEL189301
74100-002-33Hand Sanitizer1249185300 mL in 1 TANKGEL12491853001
74100-002-55Hand Sanitizer208197648 mL in 1 DRUMGEL2081976481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74100-002HAND SANITIZER (ALCOHOL) GEL [GEMINI INDUSTRIES INC.]1Legacy NDC, 4 package rows20200509_a4e97b02-e92c-b0a3-e053-2a95a90a3192.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
74100-00274100-002-01, 74100-002-05, 74100-002-55, 74100-002-33

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
a4e9f0ff-eb32-a60f-e053-2a95a90a843fa4e97b02-e92c-b0a3-e053-2a95a90a31922020-05-05WarningsExact identifier
spl id: a4e9f0ff-eb32-a60f-e053-2a95a90a843f
spl set id: a4e97b02-e92c-b0a3-e053-2a95a90a3192