FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Hobo Inc
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:06

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Fragrance (0.200% v/v)
  5. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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

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, hydrogen peroxide, fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 74111-101-30 30 mL label30 mL label

60 mL NDC: 74111-101-60 60 mL Label60 mL Label

480 mL NDC: 74111-101-16 480 mL Label480 mL Label

960 mL NDC: 74111-101-32 960 mL Label960 mL Label

3785 mL NDC: 74111-101-01 3785 mL Label3785 mL Label

9460 mL NDC: 74111-101-25 9460 mL Label9460 mL Label

18925 mL NDC: 74111-101-05 18925 mL Label18925 mL Label

208175 mL NDC: 74111-101-55 208175 mL Label208175 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

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
74111-101-012023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-052023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-162023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-252023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-302023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-322023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-552023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced
74111-101-602023-07-28C16284748780-10191ceaa-6a81-198a-e063-dbdaa90aec3eHand Sanitizer-Fragranced

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74111-101-01Hand Sanitizer3785 mL in 1 BOTTLELIQUID37852
74111-101-05Hand Sanitizer18925 mL in 1 PAILLIQUID189252
74111-101-16Hand Sanitizer480 mL in 1 BOTTLELIQUID4802
74111-101-25Hand Sanitizer9460 mL in 1 JUGLIQUID94602
74111-101-30Hand Sanitizer30 mL in 1 BOTTLELIQUID302
74111-101-32Hand Sanitizer960 mL in 1 BOTTLELIQUID9602
74111-101-55Hand Sanitizer208175 mL in 1 DRUMLIQUID2081752
74111-101-60Hand Sanitizer60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74111-101HAND SANITIZER (ALCOHOL) LIQUID [HOBO INC]2Legacy NDC, 8 package rows20220118_a49d0ad5-02a1-1782-e053-2995a90a5043.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74111-10174111-101-01, 74111-101-16, 74111-101-32, 74111-101-30, 74111-101-60, 74111-101-25, 74111-101-05, 74111-101-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CINNAMALDEHYDESR60A3XG0FIACT
ISOAMYL ACETATEZ135787824IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
HEXAMETHYLINDANOPYRAN14170060ATIACT

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
d5cc071c-2253-c643-e053-2995a90a60e6a49d0ad5-02a1-1782-e053-2995a90a50432022-01-17WarningsExact identifier
spl id: d5cc071c-2253-c643-e053-2995a90a60e6
spl set id: a49d0ad5-02a1-1782-e053-2995a90a5043

Reported adverse events (FAERS/openFDA)#

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