FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
MEDICORE MED LLC
Effective date
2021-11-30
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 23:45:12

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 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.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Denatured ALCOHOL 80% V/V

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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

When using this product 

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

  • Store between 15 - 30C (59 - 86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive igradients

INACTIVE INGREDIENT SECTION

glicerin, hidrogen peroxide, purified woter USP

Package Labeling:950ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:236ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

Package Labeling:473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBoxBox2Box2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN17
1039339ethanol 0.8 ML/ML Topical SolutionSCD17
1039339ethanol 80 % Topical SolutionSY17

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
78112-080-012023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-022023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-032023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-062023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-072023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-082023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer
78112-080-092023-01-30C16284748780-1f386c649-e7a8-0266-e053-dadaa90a7c1aHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78112-080-01Hand Sanitizer950 mL in 1 BOTTLELIQUID95017
78112-080-02Hand Sanitizer473 mL in 1 BOTTLELIQUID47317
78112-080-03Hand Sanitizer236 mL in 1 BOTTLELIQUID23617
78112-080-06Hand Sanitizer59 mL in 1 BOTTLELIQUID5917
78112-080-07Hand Sanitizer3800 mL in 1 BOTTLELIQUID380017
78112-080-08Hand Sanitizer118 mL in 1 BOTTLELIQUID11817
78112-080-09Hand Sanitizer30 mL in 1 BOTTLELIQUID3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78112-080HAND SANITIZER (ALCOHOL) LIQUID [MEDICORE MED LLC]17Legacy NDC, 7 package rows20211201_2db72a20-48b8-41a1-9882-a296d18efa56.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
78112-08078112-080-01, 78112-080-03, 78112-080-07, 78112-080-02, 78112-080-06, 78112-080-08, 78112-080-09

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
d2090681-4987-93a4-e053-2a95a90a1ecd2db72a20-48b8-41a1-9882-a296d18efa562021-11-30WarningsExact identifier
spl id: d2090681-4987-93a4-e053-2a95a90a1ecd
spl set id: 2db72a20-48b8-41a1-9882-a296d18efa56

Reported adverse events (FAERS/openFDA)#

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