FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Medek, LLC
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:46

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store below 110F (43C) Avoid freezing. May discolor certain fabrics/surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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 (.5% v/v).
  3. Carbopol (0.5% v/v).
  4. Triethanolamine (0.4% v/v)
  5. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Antiseptic Hand Sanitizer to reduce germs on skin. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from open flame and sources of heat.

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, rash or redness 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, rash or redness 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

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • Avoid freezing. May discolor certain fabrics/surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbopol, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

976 mL NDC: 75432-003-01

1lt kepter1lt kepter

3786 mL NDC: 75432-003-02

1 gal kepter1 gal kepter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75432-003-012022-01-28C16284748780-1d6a99b39-dd58-a426-e053-dadaa90af4c2Kepter Hand Sanitizer
75432-003-022022-01-28C16284748780-1d6a99b39-dd58-a426-e053-dadaa90af4c2Kepter Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75432-003-01Hand Sanitizer976 mL in 1 BOTTLEGEL9762
75432-003-02Hand Sanitizer3786 mL in 1 BOTTLEGEL37862

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75432-003HAND SANITIZER (ALCOHOL) GEL [MEDEK, LLC]2Legacy NDC, 2 package rows20200624_a73d415c-9c32-b56f-e053-2a95a90abb35.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
75432-00375432-003-01, 75432-003-02

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
a8c8aac8-0e82-3bec-e053-2a95a90af7e7a73d415c-9c32-b56f-e053-2a95a90abb352020-06-23WarningsExact identifier
spl id: a8c8aac8-0e82-3bec-e053-2a95a90af7e7
spl set id: a73d415c-9c32-b56f-e053-2a95a90abb35

Reported adverse events (FAERS/openFDA)#

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