FDA.reportPublic FDA data

Home Hand Sanitizer

Manufacturer
UNIWARE HOUSEWARE CORP.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:22

Label at a glance#

ProductHome Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria  on the skin.

Dosage and administration

Put enough product in your palm to cover hands and rub hands until dry. Children under 6 years of age should be supervised when using the product.

Storage and handling

Store below 110° F (43° C). May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. 

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria  on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with face, eyes and broken skin. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

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

  • Put enough product in your palm to cover hands and rub hands until dry.
  • Children under 6 years of age should be supervised when using the product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110° F (43° C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), lsopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 2-amino-2-methyl-1-propanol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78712-001-012022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-022022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-032022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-042022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-052022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-062022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-072022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-082022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c
78712-001-092022-01-28C16284748780-1d6a99b39-dc4e-a426-e053-dadaa90af4c2f82dd433-b8d3-4b84-a90e-cab200bb0f7c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78712-001-01Home Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL501
78712-001-02Home Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
78712-001-03Home Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
78712-001-04Home Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
78712-001-05Home Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
78712-001-06Home Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001
78712-001-07Home Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
78712-001-08Home Hand Sanitizer2000 mL in 1 BOTTLE, PLASTICGEL20001
78712-001-09Home Hand Sanitizer5000 mL in 1 BOTTLE, PLASTICGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78712-001HOME HAND SANITIZER (ALCOHOL) GEL [UNIWARE HOUSEWARE CORP.]1Legacy NDC, 9 package rows20200612_f82dd433-b8d3-4b84-a90e-cab200bb0f7c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78712-00178712-001-01, 78712-001-02, 78712-001-03, 78712-001-04, 78712-001-05, 78712-001-06, 78712-001-07, 78712-001-08, 78712-001-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
3a434346-e0e8-4a7d-8226-ac2af537e6e2f82dd433-b8d3-4b84-a90e-cab200bb0f7c2020-06-09WarningsExact identifier
spl id: 3a434346-e0e8-4a7d-8226-ac2af537e6e2
spl set id: f82dd433-b8d3-4b84-a90e-cab200bb0f7c

Reported adverse events (FAERS/openFDA)#

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