FDA.reportPublic FDA data

Hand Sanitizer for Healthcare

Manufacturer
American Chemical Solutions LLC
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:35:48

Label at a glance#

ProductHand Sanitizer for Healthcare
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 80% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water

SPL UNCLASSIFIED SECTION

American Chemical Solutions, LLC
2406 Roberts Street

Muskegon, MI 49444

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERICAN CHEMICAL SOLUTIONS
Hand Sanitizer for Healthcare
Alcohol Antiseptic 80% Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
1 US Gallon (3.8 L)

ACS_HandSanitizer_1Gal PDPACS_HandSanitizer_1Gal PDP

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
74878-00174878-001-01, 74878-001-02, 74878-001-03, 74878-001-04, 74878-001-05

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
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
c77add4f-eff1-8b34-e053-2995a90a1a28a2cb6dfc-875a-9d06-e053-2995a90ab00e2021-07-19WarningsExact identifier
spl set id: a2cb6dfc-875a-9d06-e053-2995a90ab00e

Reported adverse events (FAERS/openFDA)#

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