FDA.reportPublic FDA data

HEALTH E Alcohol-Free Antiseptic

Manufacturer
Petra Hygienic Systems Int Ltd
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:07:43

Label at a glance#

ProductHEALTH E Alcohol-Free Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin.

Dosage and administration

Tear V notch located on top of the plastic bag. Pull out the first wipe approximately 6 to 8 inches from the center of the roll. Place entire bag inside of center pull dispenser. Thread the wipe through the opening on the dispenser. Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up. Apply topically to the skin to ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

  • For external use only
  • May irritate eyes

•  Keep out reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

unless under adult supervision

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear V notch located on top of the plastic bag.
  • Pull out the first wipe approximately 6 to 8 inches from the center of the roll.
  • Place entire bag inside of center pull dispenser.
  • Thread the wipe through the opening on the dispenser.
  • Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN7
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD7
1038558benzalkonium chloride 0.13 % Topical ClothSY7
1038558benzalkonium chloride 0.13 % Topical SwabSY7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY7
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42326-090-01HEALTH E Alcohol-Free Antiseptic1.3 mL in 1 PATCHCLOTH1.37
42326-090-01HEALTH E Alcohol-Free Antiseptic1000 in 1 BAGCLOTH10007

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
42326-09042326-090-01

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
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
LAURYL BETAINEY4P927Q133IACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLPARABEN3QPI1U3FV8IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
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
HEALTH E Alcohol-Free AntisepticBENZALKONIUM CHLORIDEPetra Hygienic Systems Int Ltdc67ec691-d82c-4762-a925-fb338755b7df2025-07-17WarningsExact identifier
ndc (package): 42326-090-01
ndc (product): 42326-090
ndc11 (package): 42326009001
spl id: 3a238712-4cfb-f977-e063-6394a90a04ed
spl set id: c67ec691-d82c-4762-a925-fb338755b7df

Reported adverse events (FAERS/openFDA)#

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