FDA.reportPublic FDA data

ProCure Antimicrobial Hand

Manufacturer
Twin Med LLC
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:34

Label at a glance#

ProductProCure Antimicrobial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

Uses handwashing to help decrease bacteria on the skin

Dosage and administration

Directions wet hands apply product and thoroughly cover hands with lather for 30 seconds rinse well and dry hands completely

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.13%)

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Uses handwashing to help decrease bacteria on the skin

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours

Keep out of reach of children

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

Directions

  • wet hands
  • apply product and thoroughly cover hands with lather for 30 seconds
  • rinse well and dry hands completely

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Cetrimonium Chloride, Sodium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Sodium Lauriminodipropionate, Fragrance, Citric Acid, Disodium EDTA, Methylisothiazolinone, Methylchloroisothiazolinone, Yellow #5, Red #33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Soap ImageHand Soap Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-041-10ProCure Antimicrobial Hand1000 mL in 1 BAGSOAP10002
55681-041-75ProCure Antimicrobial Hand222 mL in 1 BOTTLE, PUMPSOAP2222
55681-041-80ProCure Antimicrobial Hand800 mL in 1 BAGSOAP8002

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-04155681-041-75, 55681-041-80, 55681-041-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM7FLD91C86KIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
WATER059QF0KO0RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM CHLORIDE451W47IQ8XIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
SORBITOL506T60A25RIACT
SODIUM LAURIMINODIPROPIONATE7G447D0DH9IACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
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
ProCure Antimicrobial HandHAND SOAP BENZALKONIUM CHLORIDE (0.13%)Twin Med LLC3dfbe75e-9906-18d7-e063-6294a90ac32e2025-09-04WarningsExact identifier
ndc (package): 55681-041-75
ndc (package): 55681-041-10
ndc (package): 55681-041-80
ndc (product): 55681-041
ndc11 (package): 55681004175
ndc11 (package): 55681004180
ndc11 (package): 55681004110
spl id: 3dfec50e-44e8-9395-e063-6394a90ae44b
spl set id: 3dfbe75e-9906-18d7-e063-6294a90ac32e

Reported adverse events (FAERS/openFDA)#

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