Hand Sanitizer

Manufacturer
Montezuma Winery LLC
Effective date
2020-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:08:13

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure14 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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Back ingredients labelBack ingredients label

Front product labelFront product label

Alcohol 80% v/v. Purpose: Antiseptic

80 percent alcohol back80 percent alcohol back80 percent alcohol front80 percent alcohol front

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Back ingredient labelBack ingredient label

Front product imageFront product image

Antiseptic, Hand Sanitizer

80 percent Alcohol back label80 percent Alcohol back label80 percent alcohol front label80 percent alcohol front label

Use

INDICATIONS & USAGE SECTION

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

Back product ingredients labelBack product ingredients label

Front Product labelFront Product label

80 percent alcohol back label80 percent alcohol back label

750 ml 80 percent alcohol front label750 ml 80 percent alcohol front label

Warnings

WARNINGS SECTION

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

Back product ingredient labelBack product ingredient label

750 ml 80% alcohol back label750 ml 80% alcohol back label80% alcohol front label80% alcohol front label

Do not use

OTC - DO NOT USE SECTION

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

Back ingredient label with warningBack ingredient label with warning

80% alcohol back label80% alcohol back label750ml 80 percent front label750ml 80 percent front label

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.

Back ingredient label when usingBack ingredient label when using

750ml 80% alcohol back label750ml 80% alcohol back label

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Back ingredient label stop useBack ingredient label stop use

80% alcohol back80% alcohol back80% alcohol front80% alcohol front

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.

Back ingredient label keep out of reachBack ingredient label keep out of reach

750ml 80% alcohol back750ml 80% alcohol back750ml 80% front label750ml 80% front label

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.

Back ingredient label dosageBack ingredient label dosage

750ml 80 alcohol back750ml 80 alcohol back750ml 80 alcohol front750ml 80 alcohol front

Other information

STORAGE AND HANDLING SECTION

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

Back ingredient label other informationBack ingredient label other information

750ml 80% Alcohol back750ml 80% Alcohol back750ml 80% Alcohol front750ml 80% Alcohol front

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Back ingredient label inactive ingredientsBack ingredient label inactive ingredients

750ml 80 percent alcohol back label750ml 80 percent alcohol back label750 ml 80% alcohol front label750 ml 80% alcohol front label

RECENT MAJOR CHANGES SECTION

Indications and Usage

Back label image description corrected. Image was deleted and re-uploaded because it was undefined.

Inserted image above content wording. Deleted and re-uploaded

Dosage and Administration

Pressed enter to get rid of a bullet point so I could insert image

Indications and Usage 4/2020 - added new packaging label for 750ml 80% alcohol

Dosage and administration 4/2020 - added new packaging label for 750ml 80% alcohol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

375 ml NDC: 74357-0001-1

back ingredients labelback ingredients labelFront package labelFront package label

750 ml NDC: 74357-0002-2

750 80 percent alcohol back label750 80 percent alcohol back label

750 ml 80 percent front750 ml 80 percent front

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74357-0001-1Hand Sanitizer750 mL in 1 BOTTLE, GLASSLIQUID7502
74357-0002-1Hand Sanitizer750 mL in 1 BOTTLE, GLASSLIQUID7502
74357-0002-2Hand Sanitizer750 mL in 1 BOTTLE, GLASSLIQUID7502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74357-0001HAND SANITIZER (DR MONTYS GERM BUSTER) LIQUID HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [MONTEZUMA WINERY LLC]2Legacy NDC, 1 package rows20200428_a23a15c4-1b08-e7ac-e053-2995a90ad31b.zip
74357-0002HAND SANITIZER (DR MONTYS GERM BUSTER) LIQUID HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [MONTEZUMA WINERY LLC]2Legacy NDC, 2 package rows20200428_a23a15c4-1b08-e7ac-e053-2995a90ad31b.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
74357-000174357-0001-1
74357-000274357-0002-1, 74357-0002-2

Ingredients#

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

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

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
a3928c7b-85dc-3d1e-e053-2a95a90a425ca23a15c4-1b08-e7ac-e053-2995a90ad31b2020-04-18WarningsExact identifier
spl id: a3928c7b-85dc-3d1e-e053-2a95a90a425c
spl set id: a23a15c4-1b08-e7ac-e053-2995a90ad31b

Reported adverse events (FAERS/openFDA)#

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