Holy Hands Hand Sanitizer

Manufacturer
Encore Industrial Products, LLC
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:02

Label at a glance#

ProductHoly Hands Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
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

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, 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. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

spl unclassified sectionspl unclassified section

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic otc active ingredientotc active ingredient

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer otc purpose sectionotc purpose section

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. indications and usage sectionindications and usage section

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds otc do not use sectionotc do not use 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 when using sectionotc when using section

OTC - STOP USE SECTION

otc stop use sectionotc stop use sectionStop 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. otc keep out of reach of children sectionotc keep out of reach of children section

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. directions dosage and administration sectiondirections dosage and administration section

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP inactive ingredient sectioninactive ingredient section

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75 ml NDC: 74332-002-00

75 ml label75 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN2
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD2
1039900isopropyl alcohol 75 % 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
74332-002-002022-01-28C16284748780-1d6a99b39-c3c1-a426-e053-dadaa90af4c2Holy Hands Hand Sanitizer
74332-002-012022-01-28C16284748780-1d6a99b39-c3c1-a426-e053-dadaa90af4c2Holy Hands Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74332-002-00Holy Hands Hand Sanitizer75 mL in 1 BOTTLE, PUMPLIQUID752
74332-002-01Holy Hands Hand Sanitizer354 mL in 1 BOTTLE, PUMPLIQUID3542

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74332-002HOLY HANDS HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [ENCORE INDUSTRIAL PRODUCTS, LLC]2Legacy NDC, 2 package rows20200626_a3bbec16-7128-7e77-e053-2995a90aebd7.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
74332-00274332-002-00, 74332-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
a8ed793e-9898-d815-e053-2995a90a3d31a3bbec16-7128-7e77-e053-2995a90aebd72020-06-25WarningsExact identifier
spl id: a8ed793e-9898-d815-e053-2995a90a3d31
spl set id: a3bbec16-7128-7e77-e053-2995a90aebd7

Reported adverse events (FAERS/openFDA)#

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