FDA.reportPublic FDA data

OPI Antiseptic Foaming Hand Cleaner

Manufacturer
OPI Correctional Industries | Canberra Corporation
Effective date
2011-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:24

Label at a glance#

ProductOPI Antiseptic Foaming Hand Cleaner
Active ingredientchloroxylenol
Label structure8 sections

Indications and uses

Helps reduce bacteria that potentially can cause disease Helps prevent cross contamination by hand contact

Dosage and administration

Apply cleaner to palm of hand Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds Rinse with water until all cleaner is removed from hands Dry completely (incomplete drying may lead to chapped skin).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol (1.49% w/w)

Purpose:

OTC - PURPOSE SECTION

Anti-Microbial Hand Cleanser

Uses

INDICATIONS & USAGE SECTION

  • Helps reduce bacteria that potentially can cause disease
  • Helps prevent cross contamination by hand contact

Warnings

WARNINGS SECTION

  • For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • In case of eye contact flush with water for 15 minutes, if irritation persists, get medical attention.
  • In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply cleaner to palm of hand
  • Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds
  • Rinse with water until all cleaner is removed from hands
  • Dry completely (incomplete drying may lead to chapped skin).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, 2-Propanol, Sodium Laureth Sulfate, Cocoamidopropyl Betaine, Cocoamphoproprionate,

Cocoamide, Hydroxyethyl Cellulose, Triclosan

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label:

OPI

PERSONAL CARE SUPPLIES

ANTISEPTIC FOAMING HAND CLEANER

An Anti-Microbial Lotion Hand

Wash Formulated To Clean

Effectively, Yet Gently.

See side panel for additional information.

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092578chloroxylenol 1.49 % Medicated LIquid SoapPSN1
1092578chloroxylenol 14.9 MG/ML Medicated Liquid SoapSCD1
1092578chloroxylenol 1.49 % Medicated LIquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43196-510-052019-10-29C16284748780-1960f7f55-cb60-8e05-e053-dbdaa90a074aOPI Antiseptic Foaming Hand Cleaner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43196-510-05OPI Antiseptic Foaming Hand Cleaner3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43196-510OPI ANTISEPTIC FOAMING HAND CLEANER (CHLOROXYLENOL) LIQUID [OPI CORRECTIONAL INDUSTRIES]1Legacy NDC, 1 package rows20110310_07177a9e-d1b0-4ce6-9da9-3c24454d715f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
chloroxylenolACTIVE INGREDIENT0F32U78V2Q1
chloroxylenolACTIVE MOIETY0F32U78V2Q1
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KX1
coco diethanolamideINACTIVE INGREDIENT92005F972D1
hydroxyethyl cellulose (2000 CPS at 1%)INACTIVE INGREDIENTS38J6RZN161
isopropyl alcoholINACTIVE INGREDIENTND2M4163021
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP01
triclosanINACTIVE INGREDIENT4NM5039Y5X1
waterINACTIVE INGREDIENT059QF0KO0R1

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
43196-51043196-510-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
chloroxylenol0F32U78V2QACTIB
water059QF0KO0RIACT
sodium laureth sulfateBPV390UAP0IACT
cocamidopropyl betaine5OCF3O11KXIACT
hydroxyethyl cellulose (2000 CPS at 1%)S38J6RZN16IACT
isopropyl alcoholND2M416302IACT
coco diethanolamide92005F972DIACT
triclosan4NM5039Y5XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
sodium laureth sulfateSODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
sodium laureth sulfateSODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
coco diethanolamideCOCO DIETHANOLAMIDE92005F972DSHAMPOO / TOPICAL600 mgExact identifier — unii candidate
5 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SPRAY / NASAL0.1 mg/0.2mlExact identifier — unii candidate
15 equally ranked IID candidates
coco diethanolamideCOCO DIETHANOLAMIDE92005F972DCREAM / TOPICAL30 mgExact identifier — unii candidate
5 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
sodium laureth sulfateSODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii candidate
5 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
sodium laureth sulfateSODIUM LAURETH-3 SULFATEBPV390UAP0TABLET / ORAL0.91 mgExact identifier — unii candidate
5 equally ranked IID candidates
sodium laureth sulfateSODIUM LAURETH-3 SULFATEBPV390UAP0CAPSULE / ORAL3.5 mgExact identifier — unii candidate
5 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
coco diethanolamideCOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
coco diethanolamideCOCO DIETHANOLAMIDE92005F972DSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
15 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
15 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
hydroxyethyl cellulose (2000 CPS at 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
15 equally ranked IID candidates
coco diethanolamideCOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii candidate
5 equally ranked IID candidates

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
35e13ed0-1005-436c-8865-dffd9ac4631607177a9e-d1b0-4ce6-9da9-3c24454d715f2011-03-07WarningsExact identifier
spl id: 35e13ed0-1005-436c-8865-dffd9ac46316
spl set id: 07177a9e-d1b0-4ce6-9da9-3c24454d715f

Reported adverse events (FAERS/openFDA)#

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