FDA.reportPublic FDA data

Real clean hands

Manufacturer
FUSE MANUFACTURING LLC
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:01

Label at a glance#

ProductReal clean hands
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

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 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

  • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110oF (43oC).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, ethyl alcohol, fragrance, glycerin, Triethanolamine, water (aqua)

Questions? support@rch.com 

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79371-001-012022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-022022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-032022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-042022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-052022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-062022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295
79371-001-072022-01-28C16284748780-1d6a99b39-907d-a426-e053-dadaa90af4c25305fd23-8368-45ae-a9d6-7f92d521f295

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79371-001-01Real clean hands5 mL in 1 BOTTLE, PLASTICGEL51
79371-001-02Real clean hands30 mL in 1 BOTTLE, PLASTICGEL301
79371-001-03Real clean hands60 mL in 1 BOTTLE, PLASTICGEL601
79371-001-04Real clean hands120 mL in 1 BOTTLE, PLASTICGEL1201
79371-001-05Real clean hands200 mL in 1 BOTTLE, PLASTICGEL2001
79371-001-06Real clean hands250 mL in 1 BOTTLE, PLASTICGEL2501
79371-001-07Real clean hands500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79371-001REAL CLEAN HANDS (ISOPROPYL ALCOHOL) GEL [FUSE MANUFACTURING LLC]1Legacy NDC, 7 package rows20200704_5305fd23-8368-45ae-a9d6-7f92d521f295.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
79371-00179371-001-01, 79371-001-02, 79371-001-03, 79371-001-04, 79371-001-05, 79371-001-06, 79371-001-07

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
ISOPROPYL ALCOHOLND2M416302ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT

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
26bace75-ab57-4043-9339-92240ca09acd5305fd23-8368-45ae-a9d6-7f92d521f2952020-07-03WarningsExact identifier
spl id: 26bace75-ab57-4043-9339-92240ca09acd
spl set id: 5305fd23-8368-45ae-a9d6-7f92d521f295

Reported adverse events (FAERS/openFDA)#

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