Clean Machine

Manufacturer
Tom's Town Distilling Co.
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:55

Label at a glance#

ProductClean Machine
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

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. 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. 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

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, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785.412 ml label3785.412 ml label3785.412 ml label NDC 77227-990-01 (NDC code on back label)

3785.412 4 pack box label3785.412 4 pack box label

15,141.648ml NDC 77227-990-02 (NDC and Quantity numbers filled in blank box)

1892.741892.74

1892.74 ml label NDC 77227-990-03 (NDC code on back label)

1892.74 4 pack box1892.74 4 pack box1892.74 ml label 4 pack box NDC 77227-990-04 (NDC and Quantity numbers are filled into blank box)

1892.74 6 pack box1892.74 6 pack box1892.74 ml 6 pack box NDC 77227-990-06 (NDC code and quantity filled into blank box)

300 gallon tote label300 gallon tote label

1135623.6 ml (300 gallon tote) NDC 77227-990-05 (NDC code and Quantity filled into blank box.)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

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
77227-990-01Clean Machine3785.412 mL in 1 BOTTLE, PLASTICLIQUID3785.4121
77227-990-02Clean Machine15141.648 mL in 1 BOXLIQUID15141.6481
77227-990-03Clean Machine1892.706 mL in 1 BOTTLE, PLASTICLIQUID1892.7061
77227-990-04Clean Machine7570.824 mL in 1 BOXLIQUID7570.8241
77227-990-05Clean Machine1135623.54 mL in 1 TANKLIQUID1135623.541
77227-990-06Clean Machine11356.236 mL in 1 BOXLIQUID11356.2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77227-990CLEAN MACHINE (ALCOHOL) LIQUID [TOM'S TOWN DISTILLING CO.]1Legacy NDC, 6 package rows20200507_a49a242e-b062-2598-e053-2995a90afdb7.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
77227-99077227-990-01, 77227-990-04, 77227-990-02, 77227-990-03, 77227-990-05, 77227-990-06

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

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
a49a2e6a-f636-f175-e053-2a95a90a680ba49a242e-b062-2598-e053-2995a90afdb72020-05-01WarningsExact identifier
spl id: a49a2e6a-f636-f175-e053-2a95a90a680b
spl set id: a49a242e-b062-2598-e053-2995a90afdb7

Reported adverse events (FAERS/openFDA)#

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