FDA.reportPublic FDA data

TTC Sanitizer 80

Manufacturer
Tennessee Technical Coatings, Corp.
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:35:16

Label at a glance#

ProductTTC Sanitizer 80
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

eth 4ozeth 4oz32322752758oz8oz5gal5gal16oz16oz55gal55gal3.785 L NDC: 76921-001-01 Ethanol 1 gallonEthanol 1 gallon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

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
76921-001-012022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-042022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-052022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-082022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-162022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-322022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-552022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer
76921-001-752022-01-28C16284748780-1d6a99b39-b55f-a426-e053-dadaa90af4c24.30.2020 80 Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76921-001-01TTC Sanitizer 803.785 L in 1 JUGLIQUID3.7853
76921-001-04TTC Sanitizer 800.118 L in 1 BOTTLE, PLASTICLIQUID0.1183
76921-001-05TTC Sanitizer 8018.925 L in 1 PAILLIQUID18.9253
76921-001-08TTC Sanitizer 800.236 L in 1 BOTTLE, PLASTICLIQUID0.2363
76921-001-16TTC Sanitizer 800.473 L in 1 BOTTLE, PLASTICLIQUID0.4733
76921-001-32TTC Sanitizer 800.946 L in 1 BOTTLE, PLASTICLIQUID0.9463
76921-001-55TTC Sanitizer 80208.175 L in 1 DRUMLIQUID208.1753
76921-001-75TTC Sanitizer 801040.875 L in 1 TANKLIQUID1040.8753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76921-001TTC SANITIZER 80 LIQUID [TENNESSEE TECHNICAL COATINGS, CORP.]3Legacy NDC, 8 package rows20201216_a485098b-c1c3-07b9-e053-2a95a90a6ea2.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
76921-00176921-001-01, 76921-001-05, 76921-001-55, 76921-001-75, 76921-001-04, 76921-001-08, 76921-001-16, 76921-001-32

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
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
b6861809-fe3b-66ba-e053-2995a90a0fb1a485098b-c1c3-07b9-e053-2a95a90a6ea22020-12-15WarningsExact identifier
spl id: b6861809-fe3b-66ba-e053-2995a90a0fb1
spl set id: a485098b-c1c3-07b9-e053-2a95a90a6ea2

Reported adverse events (FAERS/openFDA)#

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