FDA.reportPublic FDA data

Medline

Manufacturer
Medline Industries, LP
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:44:28

Label at a glance#

ProductMedline
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

health care personnel rub to help reduce bacteria that potentially can cause disease. recommended for repeated use

Dosage and administration

apply to clean dry hands. Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • health care personnel rub 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.

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

  • apply to clean dry hands.
  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

OTHER SAFETY INFORMATION

  • not made with natural rubber latex
  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-20 alkyl acrylate crosspolymer, diisopropanolamine 85%, PPG-20 methyl glucose ether, water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 oz8 oz

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
53329-21653329-216-08

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
DIISOPROPANOLAMINE0W44HYL8T5IACT
PPG-20 METHYL GLUCOSE ETHER3WV1T97D3KIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
f4203ee6-1d78-636f-e053-2a95a90a0c0eadf6d7d8-6923-25d1-e053-2a95a90a00e52023-02-07WarningsExact identifier
spl set id: adf6d7d8-6923-25d1-e053-2a95a90a00e5

Reported adverse events (FAERS/openFDA)#

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