FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Tenn South Distillery LLC dba Big Machine Distillery
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:19:43

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

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, distilled water, isopropyl alcohol OR denatonium benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55 gal NDC: 74121-001-06

55 gal label55 gal label

55 gal NDC: 74121-001-06

ver2ver2

5 gal NDC: 74121-001-05

ver2ver2

5 gal NDC: 74121-001-05

5 gal label5 gal label

1 gal NDC: 74121-001-04

ver2ver2

1 gal NDC: 74121-001-04

1 gal NDC: 74121-001-04 IMS1 gal NDC: 74121-001-04 IMS

1 gal label1 gal label

1/2 gal NDC: 74121-001-07

1/2 gal NDC: 74121-001-071/2 gal NDC: 74121-001-07

375 mL NDC: 74121-001-03

375 mL NDC: 74121-001-03 IMS375 mL NDC: 74121-001-03 IMS375 mL NDC: 74121-001-03 TK375 mL NDC: 74121-001-03 TK

375mL label375mL label

100 mL NDC: 74121-001-02

100 mL NDC: 74121-001-02 TK100 mL NDC: 74121-001-02 TK100mL label100mL label

50mL NDC: 74121-001-01

50mL NDC: 74121-001-01 MTSU50mL NDC: 74121-001-01 MTSU

50mL NDC: 74121-001-01 Trexis50mL NDC: 74121-001-01 Trexis50mL NDC: 74121-001-01 Contr50mL NDC: 74121-001-01 Contr

50 mL label50 mL label

50mL NDC: 74121-001-01

50mL NDC: 74121-001-0150mL NDC: 74121-001-01

50mL NDC: 74121-001-01

50mL NDC: 74121-001-01 IMS50mL NDC: 74121-001-01 IMS

50 mL label50 mL label

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
74121-00174121-001-01, 74121-001-02, 74121-001-03, 74121-001-04, 74121-001-05, 74121-001-06, 74121-001-07

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d3986eb0-ca8e-210e-e053-2995a90a6274a218d8d3-af9f-4599-e053-2995a90a0ede2021-12-20WarningsExact identifier
spl id: d3986eb0-ca8e-210e-e053-2995a90a6274
spl set id: a218d8d3-af9f-4599-e053-2995a90a0ede

Reported adverse events (FAERS/openFDA)#

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