FDA.reportPublic FDA data

ANTIMICROBIAL HAND

Manufacturer
AMMMM INC
Effective date
2021-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:39

Label at a glance#

ProductANTIMICROBIAL HAND
Active ingredientCHLOROXYLENOL
Label structure8 sections

Indications and uses

A HIGH QUALITY, INSTANT LATHER FOAM WITH MOISTURIZERS AND EMOLLIENTS TO LEAVE SKIN FEELING CLEAN AND REFRESHED. EXCELLENT GENERAL PURPOSE CLEANSER FOR EVERYDAY HAND WASHING. DEVELOPS RICH LATHER. IDEAL FOR: EDUCATIONAL LIGHT COMMERCIAL HEALTH CLUB FACILITIES

Dosage and administration

APPLY ONE PUMP OF ANTIMICROBIAL HAND SOAP TO HANDS. RUB HANDS TOGETHER TO SPREAD LATHER. WASH FOR 15-20 SECONDS. RINSE AND DRY HANDS THOROUGHLY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL 0.04%

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USES

INDICATIONS & USAGE SECTION

  • A HIGH QUALITY, INSTANT LATHER FOAM WITH MOISTURIZERS AND EMOLLIENTS TO LEAVE SKIN FEELING CLEAN AND REFRESHED.
  • EXCELLENT GENERAL PURPOSE CLEANSER FOR EVERYDAY HAND WASHING.
  • DEVELOPS RICH LATHER.
  • IDEAL FOR:
  • EDUCATIONAL
  • LIGHT COMMERCIAL
  • HEALTH CLUB FACILITIES

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

IN CASE OF CONTACT WITH EYES, FLUSH EYES WITH WATER AND SEEK MEDICAL ADVICE.

DISCONTINUE USE AND CONSULT A PHYSICIAN IF IRRITATION DEVELOPS.

CONSULT WITH A PHYSICIAN IF INGESTED.

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

  • APPLY ONE PUMP OF ANTIMICROBIAL HAND SOAP TO HANDS.
  • RUB HANDS TOGETHER TO SPREAD LATHER.
  • WASH FOR 15-20 SECONDS.
  • RINSE AND DRY HANDS THOROUGHLY.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, COCAMIDOPROPYL BETAINE, AMIDES, COCO, N-(2-HYDROXYPROPYL), PCMX, RED COLOR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01B LBL (CARTON)_Antimicrobial Hand Soap 4x8_1gal01B LBL (CARTON)_Antimicrobial Hand Soap 4x8_1gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77397-103-112023-01-30C16284748780-1f386c649-dfac-0266-e053-dadaa90a7c1aAMMMM - VAQUITA ANTI-MICROBIAL HAND SOAP (Chloroxylenol 0.04%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77397-103-11ANTIMICROBIAL HAND3785 mL in 1 JUGSOAP37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77397-103ANTIMICROBIAL HAND (CHLOROXYLENOL) SOAP [AMMMM INC]1Legacy NDC, 1 package rows20210724_c7a685e1-4721-355b-e053-2995a90adabf.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77397-10377397-103-11

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
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CHLOROXYLENOL0F32U78V2QACTIB
D&C RED NO. 339DBA0SBB0LIACT

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
c7a675fa-b6b6-6237-e053-2a95a90a0406c7a685e1-4721-355b-e053-2995a90adabf2021-07-21WarningsExact identifier
spl id: c7a675fa-b6b6-6237-e053-2a95a90a0406
spl set id: c7a685e1-4721-355b-e053-2995a90adabf

Reported adverse events (FAERS/openFDA)#

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