FDA.reportPublic FDA data

Defender Collection

Manufacturer
Tiger Hospitality, LLC dba A1 American
Effective date
2020-11-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:33:01

Label at a glance#

ProductDefender Collection
Active ingredientALCOHOL
Label structure11 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. Not recommended for infants.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl 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.

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. Not recommended for infants.

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

Water, isopropyl alcohol, carbopol, glycerin, propylene glycol, aminomethyl propanol, aloe, Vitamin E, Fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78940-004-012023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-022023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-032023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-042023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-052023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-062023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-072023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-082023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-092023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-102023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc
78940-004-112023-07-28C16284748780-10191ceaa-6de0-198a-e063-dbdaa90aec3e57bd2e40-571e-436b-8b3f-eea789806fbc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78940-004-01Defender Collection3785 mL in 1 BOTTLE, PLASTICGEL37855
78940-004-02Defender Collection1893 mL in 1 BOTTLE, PLASTICGEL18935
78940-004-03Defender Collection946 mL in 1 BOTTLE, PLASTICGEL9465
78940-004-04Defender Collection473 mL in 1 BOTTLE, PLASTICGEL4735
78940-004-05Defender Collection296 mL in 1 BOTTLE, PLASTICGEL2965
78940-004-06Defender Collection236 mL in 1 BOTTLE, PLASTICGEL2365
78940-004-07Defender Collection59 mL in 1 BOTTLE, PLASTICGEL595
78940-004-08Defender Collection30 mL in 1 TUBEGEL305
78940-004-09Defender Collection25 mL in 1 TUBEGEL255
78940-004-10Defender Collection15 mL in 1 TUBEGEL155
78940-004-11Defender Collection9 mL in 1 TUBEGEL95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78940-004DEFENDER COLLECTION (ALCOHOL) GEL [TIGER HOSPITALITY, LLC DBA A1 AMERICAN]5Legacy NDC, 11 package rows20201106_57bd2e40-571e-436b-8b3f-eea789806fbc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78940-00478940-004-01, 78940-004-02, 78940-004-03, 78940-004-04, 78940-004-05, 78940-004-06, 78940-004-07, 78940-004-08, 78940-004-09, 78940-004-10, 78940-004-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
b361a01e-07d0-e70f-e053-2a95a90ad92257bd2e40-571e-436b-8b3f-eea789806fbc2020-11-05WarningsExact identifier
spl id: b361a01e-07d0-e70f-e053-2a95a90ad922
spl set id: 57bd2e40-571e-436b-8b3f-eea789806fbc

Reported adverse events (FAERS/openFDA)#

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