FDA.reportPublic FDA data

Antiseptic

Manufacturer
Moore Medical
Effective date
2017-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:10:32

Label at a glance#

ProductAntiseptic
Active ingredientBENZETHONIUM CHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Benzethonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose: Antiseptic

INDICATIONS & USAGE SECTION

Uses: For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings: For external use only.

When using this product:

Do not use in the eyes.

OTC - STOP USE SECTION

Discontinue use if irritation and redness develops.

If condition persists for more than 72 hours consult a doctor.

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

Direction:

  • Apply to hands and wet as needed.
  • Lather vigorously for at least 15 seconds.
  • Rinse thoroughly and dry.

OTHER SAFETY INFORMATION

Other information:

Protect from freezing. Avoid excessive heat

INACTIVE INGREDIENT SECTION

Purified Water, Lauramine Oxide, Lauramidopropylamine Oxide, PEG-150 Distearate,
Cocamide MEA, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin,
Iodopropynyl Carbamate, Citric Acid, Yellow 5, Red 4

OTC - QUESTIONS SECTION

Questions? Call 800-234-1464

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moore Medical

Supporting Health and Care

Reorder No. 35609

UPN# 0-0607415-35609-1

MooreBrand

Antimicrobial Hand Soap

Net Contents: 18oz (532mL)

35609 each35609 each

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moore Medical

Supporting Health and Care

Reorder No. 35610

UPN# 0-0607415-35610--

MooreBrand

Antimicrobial Hand Soap

Net Contents: 1 Gallon (3.785L)

35610 each35610 each

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moore Medical

Supporting Health and Care

Reorder No. 35611

UPN# 0-0607415-35611-5

MooreBrand

Antimicrobial Hand Soap

Net Contents: 1000ml

35611 each35611 each

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55670-803-012020-03-06C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4
55670-803-072020-03-06C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4
55670-803-082020-03-06C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4
55670-803-012020-01-31C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4
55670-803-072020-01-31C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4
55670-803-082020-01-31C16284748780-19d75b9d0-f33d-f424-e053-dadaa90a57ce5cf0dfbc-2425-4812-e053-2991aa0aaea4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55670-80355670-803-07, 55670-803-01, 55670-803-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT

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
a030c528-d77d-3c9e-e053-2a95a90a7f1f5cf0dfbc-2425-4812-e053-2991aa0aaea42020-03-06WarningsExact identifier
spl set id: 5cf0dfbc-2425-4812-e053-2991aa0aaea4

Reported adverse events (FAERS/openFDA)#

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