FDA.reportPublic FDA data

Apres Foaming Hand Sanitizer

Manufacturer
Petra Hygienic Systems International Limited
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:29

Label at a glance#

ProductApres Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride – 0.13% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

Warnings

WARNINGS SECTION

For external use only.

Stop use and consult a doctor/healthcare provider if :

OTC - STOP USE SECTION

Irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help.

Directions

DOSAGE & ADMINISTRATION SECTION

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

-Water, Cetyltrimethylammonium Chloride, Lauryltrimethylammonium Chloride, Dihydroxyethyl Cocoamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42326-580-012025-02-07C16284748780-12cef2736-a78e-d83d-e063-dadaa90ab31fApres Foaming Hand Sanitizer
42326-580-012025-01-30C16284748780-12cef2736-a78e-d83d-e063-dadaa90ab31fApres Foaming Hand Sanitizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42326-580APRES FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [PETRA HYGIENIC SYSTEMS INTERNATIONAL LIMITED]3Legacy NDC20250210_b5f707c4-699d-0c9e-e053-2995a90aa934.zip

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
42326-58042326-580-01

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
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
GLYCERETH-17 COCOATE3057VPT0KCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
396c86d2-9068-d537-e063-6394a90adad7b5f707c4-699d-0c9e-e053-2995a90aa9342025-07-08WarningsExact identifier
spl set id: b5f707c4-699d-0c9e-e053-2995a90aa934

Reported adverse events (FAERS/openFDA)#

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