FDA.reportPublic FDA data

ACS ANTISEPTIC HAND SANITIZER FOAM

Manufacturer
American Chemical Systems II, LLC
Effective date
2022-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:22

Label at a glance#

ProductACS ANTISEPTIC HAND SANITIZER FOAM
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride .13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
• irritation or redness develop
• condition persists for more than 72 hours

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

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera (Aloe barbadensis) leaf juice, betaine, fragrance, glycerin, propanediol, tocopheryl acetate, water

Questions?

OTC - QUESTIONS SECTION

+1-800-889-3489
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

READ PRECAUTIONS CAREFULLY
Safety Data Sheet (SDS) is available at:
americanchemicalsystemsii.com

WARNING
Harmful if Swallowed.

SDS    Tech Sheet

Manufactured by:
AMERICAN CHEMICAL SYSTEMS II, LLC
3505 W. 29th Street South, Wichita, Kansas 67217

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75044-251-302022-03-11C16284748780-1d6a99b39-761d-a426-e053-dadaa90af4c2ACS ANTISEPTIC HAND SANITIZER FOAM
75044-251-302022-01-28C16284748780-1d6a99b39-761d-a426-e053-dadaa90af4c2ACS ANTISEPTIC HAND SANITIZER FOAM

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75044-25175044-251-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BETAINE3SCV180C9WIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
cd5735b6-80d8-4bd1-8697-a9a2b7709100a3bc0ff3-6f13-4c50-882c-181173e5f7502022-03-11WarningsExact identifier
spl id: cd5735b6-80d8-4bd1-8697-a9a2b7709100
spl set id: a3bc0ff3-6f13-4c50-882c-181173e5f750

Reported adverse events (FAERS/openFDA)#

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