FDA.reportPublic FDA data

Fenz Hand, Skin and Wound Sanitizer

Manufacturer
Katan Technologies USA, LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 23:46:40

Label at a glance#

ProductAplaus Hand and Skin Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand and skin sanitizing to decrease microbes on skin Recommended for repeated use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Benzalkonium Chloride 0.1%..................................Antimicrobial

Uses

OTC - PURPOSE SECTION

For hand and skin sanitizing to decrease microbes on skin
Recommended for repeated use

INSTRUCTIONS FOR USE SECTION

Apply a small amount to hands or skin.
Rub thoroughly over surfaces. Rub briskly until dry.

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Polysilsesquioxane Steardimonium Chloride

PH Simply Hand & Skin Sanitiser

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active ingredient Purpose

Benzalkonium Chloride 0.13%..................................Antimicrobial

Uses

•For hand and skin sanitizing
•Recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•Apply a small amount to hands or skin.
•Rub thoroughly over surfaces. Rub briskly until dry.

Inactive ingredients Water, Polysilsesquioxane Steardimonium Chloride, fragrance

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN13
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD13
1039012benzalkonium chloride 0.13 % Topical SpraySY13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71315-100-012022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-082022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-222022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-382022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-502022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-552022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-602022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser
71315-100-992022-07-29C16284748780-1e4f33bdf-ad85-d8a0-e053-dadaa90a6e4eAplaus Skin Sanitiser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71315-100-01Aplaus Hand and Skin Sanitizer10 mL in 1 BOTTLE, SPRAYSPRAY1013
71315-100-08Aplaus Hand and Skin Sanitizer80 mL in 1 BOTTLE, SPRAYSPRAY8013
71315-100-22Aplaus Hand and Skin Sanitizer220 mL in 1 BOTTLE, SPRAYSPRAY22013
71315-100-38Aplaus Hand and Skin Sanitizer3780 mL in 1 JUGSPRAY378013
71315-100-50Aplaus Hand and Skin Sanitizer50 mL in 1 BOTTLE, SPRAYSPRAY5013
71315-100-55Aplaus Hand and Skin Sanitizer550 mL in 1 BOTTLE, PUMPSPRAY55013
71315-100-60Aplaus Hand and Skin Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY6013
71315-100-99Aplaus Hand and Skin Sanitizer1000 mL in 1 BOTTLE, SPRAYSPRAY100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71315-100APLAUS HAND AND SKIN SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [KATAN TECHNOLOGIES USA, LLC]13Legacy NDC, 8 package rows20220114_511260a9-4bf6-1ad0-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71315-10071315-100-01, 71315-100-60, 71315-100-08, 71315-100-22, 71315-100-55, 71315-100-50, 71315-100-99, 71315-100-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
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
d57908b7-bc53-f4c7-e053-2995a90a6c17511260a9-4bf6-1ad0-e054-00144ff88e882022-01-13WarningsExact identifier
spl id: d57908b7-bc53-f4c7-e053-2995a90a6c17
spl set id: 511260a9-4bf6-1ad0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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