FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Total Import Solutions, Inc.
Effective date
2020-05-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:10:42

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 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

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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 heat or flame

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

purified water USP, Propanediol, Aloe Barbadensis Leaf Juice, Ammonium Mcryloyl Dimethyltaurate/Carboxyethyl Acrylate Crosspolymer, Tocopheryl Acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml label118 ml label

177 ml NDC: 74624-819-01 - Hand Sanitizer 177 ml

473 ml NDC: 74624-819-02 - Hand Sanitizer 473 ml

946 ml NDC: 74624-819-03 - Hand Sanitizer 946 ml

118 ml NDC: 74624-819-05 - Hand Sanitizer 118 ml

3785 ml 177 ml NDC: 74624-819-01177 ml NDC: 74624-819-01NDC: 74624-819-04 - Hand Sanitizer 3785 ml 473 ml NDC: 74624-819-02473 ml NDC: 74624-819-02 946 ml NDC: 74624-819-03946 ml NDC: 74624-819-03 3785 ml NDC: 74624-819-043785 ml NDC: 74624-819-04

18927 ml NDC: 74624-819-06 - Hand Sanitizer 18927 ml NDC: 74624-819-06 - Hand Sanitizer 18927 ml18927 ml NDC: 74624-819-06 - Hand Sanitizer 18927 mlitizer 18927 ml

113562 ml NDC: 74624-819-07 - Hand Sanitizer 113562 ml 113562 ml NDC: 74624-819-07 - Hand Sanitizer 113562 ml113562 ml NDC: 74624-819-07 - Hand Sanitizer 113562 ml208198 ml NDC: 74624-819-08 - Hand Sanitizer 208198 ml 208198 ml NDC: 74624-819-08 - Hand Sanitizer 208198 ml208198 ml NDC: 74624-819-08 - Hand Sanitizer 208198 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74624-819-012021-07-23C16284748780-1c7ccaba7-2628-fd44-e053-dadaa90aa01ba2a4ed18-8297-425d-e053-2a95a90afd9d
74624-819-022021-07-23C16284748780-1c7ccaba7-2628-fd44-e053-dadaa90aa01ba2a4ed18-8297-425d-e053-2a95a90afd9d
74624-819-032021-07-23C16284748780-1c7ccaba7-2628-fd44-e053-dadaa90aa01ba2a4ed18-8297-425d-e053-2a95a90afd9d
74624-819-042021-07-23C16284748780-1c7ccaba7-2628-fd44-e053-dadaa90aa01ba2a4ed18-8297-425d-e053-2a95a90afd9d
74624-819-052021-07-23C16284748780-1c7ccaba7-2628-fd44-e053-dadaa90aa01ba2a4ed18-8297-425d-e053-2a95a90afd9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74624-819-01Hand Sanitizer177 mL in 1 BOTTLE, PLASTICGEL1773
74624-819-02Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4733
74624-819-03Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9463
74624-819-04Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37853
74624-819-05Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74624-819HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [TOTAL IMPORT SOLUTIONS, INC.]3Legacy NDC, 5 package rows20200512_a2a4ed18-8297-425d-e053-2a95a90afd9d.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74624-81974624-819-01, 74624-819-02, 74624-819-03, 74624-819-04, 74624-819-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATEKBC00G95HIIACT

Source Document#

Source XML · Source PDF

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
a5669cb2-e0e3-d14f-e053-2995a90a8e29a2a4ed18-8297-425d-e053-2a95a90afd9d2020-05-11WarningsExact identifier
spl id: a5669cb2-e0e3-d14f-e053-2995a90a8e29
spl set id: a2a4ed18-8297-425d-e053-2a95a90afd9d

Reported adverse events (FAERS/openFDA)#

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