FDA.reportPublic FDA data

DefendX Hand Sanitizer Gel

Manufacturer
ETAILER LIMITED
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:17:19

Label at a glance#

ProductDefendX Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

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

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Triethanolamine, Vitamin E, Water

Product Label (Principal Display Panel)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Distributed by:
DefendX
99 Wall Street #570
New York, NY 10005
United States of America
www.defendxonline.com
DefendX Hand Sanitizer (2 fl oz) NDC: 78256-003-02
DefendX Hand Sanitizer (8 fl oz) NDC: 78256-003-08
DefendX Hand Sanitizer (16 fl oz) NDC: 78256-003-16
DefendX Hand Sanitizer (32 fl oz) NDC: 78256-003-32
DefendX Hand Sanitizer (64 fl oz) NDC: 78256-003-64
DefendX Hand Sanitizer (1 Gal) NDC: 78256-003-01
allall

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN3
1305100ethanol 0.75 ML/ML Topical GelSCD3
1305100ethanol 75 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78256-003-012022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel
78256-003-022022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel
78256-003-082022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel
78256-003-162022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel
78256-003-322022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel
78256-003-642022-01-28C16284748780-1d6a99b39-c31f-a426-e053-dadaa90af4c2DefendX Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78256-003-01DefendX Hand Sanitizer3785 mL in 1 JUGGEL37853
78256-003-02DefendX Hand Sanitizer59 mL in 1 BOTTLEGEL593
78256-003-08DefendX Hand Sanitizer236 mL in 1 BOTTLEGEL2363
78256-003-16DefendX Hand Sanitizer473 mL in 1 BOTTLEGEL4733
78256-003-32DefendX Hand Sanitizer946 mL in 1 BOTTLEGEL9463
78256-003-64DefendX Hand Sanitizer1892 mL in 1 BOTTLEGEL18923

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78256-003DEFENDX HAND SANITIZER (ALCOHOL) GEL [ETAILER LIMITED]3Legacy NDC, 6 package rows20200612_a6ba0852-19f3-0ae4-e053-2995a90aea95.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78256-00378256-003-08, 78256-003-02, 78256-003-16, 78256-003-32, 78256-003-64, 78256-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a7d6287e-33f2-2702-e053-2995a90a9da6a6ba0852-19f3-0ae4-e053-2995a90aea952020-06-11WarningsExact identifier
spl id: a7d6287e-33f2-2702-e053-2995a90a9da6
spl set id: a6ba0852-19f3-0ae4-e053-2995a90aea95

Reported adverse events (FAERS/openFDA)#

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