FDA.reportPublic FDA data

Medline

Manufacturer
Medline Industries, LP
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:33:54

Label at a glance#

ProductMedline
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

health care personnel hand rub to help reduce bacteria that potentially can cause disease

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

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • health care personnel hand rub to help reduce bacteria that potentially can cause disease

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 mouh. 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

OTHER SAFETY INFORMATION

  • store between 15-30ºC (59-86ºF)
  • avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE

REF: HHRUB04

RC20HND

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

53329-022-0453329-022-04

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
53329-02253329-022-04, 53329-022-08

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
cdc6c2a8-7056-085a-e053-2a95a90a4fd8a1b466ff-d8d5-c4f6-e053-2995a90acd0e2021-10-07WarningsExact identifier
spl id: cdc6c2a8-7056-085a-e053-2a95a90a4fd8
spl set id: a1b466ff-d8d5-c4f6-e053-2995a90acd0e

Reported adverse events (FAERS/openFDA)#

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