FDA.reportPublic FDA data

GUARDEX 2 IN 1 SANITIZING HAND LOTION ORANGE ZEST

Manufacturer
Nile Hudson LLC
Effective date
2020-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:55

Label at a glance#

ProductGUARDEX SANITIZING HAND
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

For hand cleaning reduce bacteria that potentially can cause disease and moisture your hands.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Do not store above 105 °F May discolor some fabrics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.095%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand cleaning reduce bacteria that potentially can cause disease and moisture your hands.

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

  • Do not store above 105 °F
  • May discolor some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Glycerides, Ethylhexyl Palmitate, Ammonium Polyacrylate, C13-C16 Isoparaffin, Laurath-30, Phenoxyethanol, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Fragrance, Panthenol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Maltodextrin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of tube labelimage of tube label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81353-026-012025-01-30C16284748780-12cef2736-75b4-d83d-e063-dadaa90ab31fGUARDEX 2 IN 1 SANITIZING HAND LOTION ORANGE ZEST

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81353-026-01GUARDEX SANITIZING HAND76.89 mL in 1 TUBELOTION76.891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81353-026GUARDEX SANITIZING HAND (BENZALKONIUM CHLORIDE) LOTION [NILE HUDSON LLC]1Legacy NDC, 1 package rows20201227_b734dc0c-9452-137e-e053-2a95a90a64bf.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81353-02681353-026-01

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
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
SHEA BUTTERK49155WL9YIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
LAURETH-30W9D845551AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C13-16 ISOPARAFFINLED42LZG6OIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PANTHENOLWV9CM0O67ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
b734f042-d5a6-3850-e053-2995a90afcb7b734dc0c-9452-137e-e053-2a95a90a64bf2020-12-24WarningsExact identifier
spl id: b734f042-d5a6-3850-e053-2995a90afcb7
spl set id: b734dc0c-9452-137e-e053-2a95a90a64bf

Reported adverse events (FAERS/openFDA)#

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