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

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Use

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

Warnings

Warnings

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

Do not use

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

Directions And Dosage

Directions

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 Label Information

Other information

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

Inactive ingredients

glycerin, purified water USP, hydroxyethylcellulose

Package Label - Principal Display Panel

3780 mL NDC: 74100-002-01 18930 mL NDC: 74100-002-05 208197648 mL NDC: 74100-002-55 124918530 mL NDC: 74100-002-33

Label Images#

3780mL
3780mL
18930mL
18930mL
208197648mL
208197648mL
124918530mL
124918530mL

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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74100-00274100-002-01, 74100-002-05, 74100-002-55, 74100-002-33

Ingredients#

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

Complete SPL Sections#

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

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

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

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 18930 mL NDC: 74100-002-05 208197648 mL NDC: 74100-002-55 124918530 mL NDC: 74100-002-33

Source Document#

Source XML