FDA.reportPublic FDA data

80% Ethyl Alcohol Gel Sanitizer

Manufacturer
Midland Products LLC
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:21:32

Label at a glance#

Product80% Ethyl Alcohol Gel 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

Water, Acrylates Copolymer, Fragrance, Aminoethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1040.98L label1040.98L label208.19L label208.19L label18.92L label18.92L label3.78L label3.78L label473.1ml label473.1ml label236.5ml label236.5ml label59ml label59ml label59 mL NDC: 77136-700-02

236.5 mL NDC: 77136-700-08

473.1 mL NDC: 77136-700-16

3785.4 mL NDC: 77136-700-10

18927.1 mL NDC: 77136-700-05

208197.6 mL NDC: 77136-700-55

1040988.2 mL NDC: 77136-700-75

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN3
1041498ethanol 0.8 ML/ML Topical GelSCD3
1041498ethanol 80 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77136-700-022022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-052022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-082022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-102022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-162022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-552022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel
77136-700-752022-01-28C16284748780-1d6a99b39-de60-a426-e053-dadaa90af4c280% Ethyl Alcohol Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77136-700-0280% Ethyl Alcohol Gel Sanitizer59 mL in 1 BOTTLE, DISPENSINGLIQUID593
77136-700-0580% Ethyl Alcohol Gel Sanitizer18927.1 mL in 1 PAILLIQUID18927.13
77136-700-0880% Ethyl Alcohol Gel Sanitizer236.5 mL in 1 BOTTLE, DISPENSINGLIQUID236.53
77136-700-1080% Ethyl Alcohol Gel Sanitizer3785.4 mL in 1 JUGLIQUID3785.43
77136-700-1680% Ethyl Alcohol Gel Sanitizer473.1 mL in 1 BOTTLE, DISPENSINGLIQUID473.13
77136-700-5580% Ethyl Alcohol Gel Sanitizer208197.6 mL in 1 DRUMLIQUID208197.63
77136-700-7580% Ethyl Alcohol Gel Sanitizer1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1040988.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77136-70080% ETHYL ALCOHOL GEL SANITIZER (ALCOHOL) LIQUID [MIDLAND PRODUCTS LLC]3Legacy NDC, 7 package rows20200716_a5f61452-5bb0-de97-e053-2a95a90a211b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77136-70077136-700-02, 77136-700-08, 77136-700-16, 77136-700-10, 77136-700-05, 77136-700-55, 77136-700-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
aa7f4d7c-464c-2a31-e053-2995a90afe2ca5f61452-5bb0-de97-e053-2a95a90a211b2020-07-10WarningsExact identifier
spl id: aa7f4d7c-464c-2a31-e053-2995a90afe2c
spl set id: a5f61452-5bb0-de97-e053-2a95a90a211b

Reported adverse events (FAERS/openFDA)#

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