FDA.reportPublic FDA data

Iris Hand Sanitizer Gel

Manufacturer
Iris LLC
Effective date
2020-10-03
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 23:30:58

Label at a glance#

ProductHygenize Hand Sanitizer
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

In children less than two 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.

Keep out of reach of children. 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 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.

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.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Glycerin, propylene glycol, carbomer, aminomethylproponal, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL label237 mL label237 mL back label237 mL back label

8 FL OZ (237 ML)

118 ml label118 ml label118 ml NDC: 74052-340-04

946.353 ml NDC: 74052-341-32946.353 ml NDC: 74052-341-32

946.353 ml NDC: 74052-341-32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN17
581662ethanol 0.7 ML/ML Topical GelSCD17
581662ethanol 70 % Topical GelSY17
581662ethyl alcohol 70 % Topical GelSY17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74052-337-012022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-022022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-032022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-042022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-082022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-102022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-122022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-162022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-172022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-282022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-342022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-382022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-552022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-337-992022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0
74052-340-042022-01-28C16284748780-1d6a99b39-6213-a426-e053-dadaa90af4c2a2677c78-958b-3b1a-e053-2995a90a6ae0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74052-337-01Iris Hand Sanitizer Gel30 mL in 1 BOTTLE, PUMPGEL3017
74052-337-02Iris Hand Sanitizer Gel59 mL in 1 BOTTLE, PUMPGEL5917
74052-337-03Iris Hand Sanitizer Gel100 mL in 1 BOTTLE, PUMPGEL10017
74052-337-04Iris Hand Sanitizer Gel118 mL in 1 BOTTLE, PUMPGEL11817
74052-337-08Iris Hand Sanitizer Gel237 mL in 1 BOTTLE, PUMPGEL23717
74052-337-10Iris Hand Sanitizer Gel296 mL in 1 BOTTLE, PUMPGEL29617
74052-337-12Iris Hand Sanitizer Gel355 mL in 1 BOTTLE, PUMPGEL35517
74052-337-16Iris Hand Sanitizer Gel473 mL in 1 BOTTLE, PUMPGEL47317
74052-337-17Iris Hand Sanitizer Gel500 mL in 1 BOTTLE, PUMPGEL50017
74052-337-28Iris Hand Sanitizer Gel3785.41 mL in 1 BOTTLE, PUMPGEL3785.4117
74052-337-34Iris Hand Sanitizer Gel1000 mL in 1 BOTTLE, PUMPGEL100017
74052-337-38Iris Hand Sanitizer Gel18927.1 mL in 1 BOTTLE, PUMPGEL18927.117
74052-337-55Iris Hand Sanitizer Gel208198 mL in 1 BOTTLE, PUMPGEL20819817
74052-337-99Iris Hand Sanitizer Gel1041000 mL in 1 BOTTLE, PUMPGEL104100017
74052-339-01Hygenize Hand Sanitizer3785.41 mL in 1 BOTTLE, PUMPGEL3785.4117
74052-339-02Hygenize Hand Sanitizer59 mL in 1 BOTTLE, PUMPGEL5917
74052-339-04Hygenize Hand Sanitizer118 mL in 1 BOTTLE, PUMPGEL11817
74052-339-08Hygenize Hand Sanitizer237 mL in 1 BOTTLE, PUMPGEL23717
74052-339-10Hygenize Hand Sanitizer296 mL in 1 BOTTLE, PUMPGEL29617
74052-339-12Hygenize Hand Sanitizer355 mL in 1 BOTTLE, PUMPGEL35517
74052-339-16Hygenize Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL47317
74052-339-28Hygenize Hand Sanitizer3785.41 mL in 1 BOTTLE, PUMPGEL3785.4117
74052-339-32Hygenize Hand Sanitizer100 mL in 1 BOTTLE, PUMPGEL10017
74052-339-33Hygenize Hand Sanitizer6 in 1 CARTONGEL617
74052-339-34Hygenize Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL100017
74052-339-38Hygenize Hand Sanitizer18927.1 mL in 1 BOTTLE, PUMPGEL18927.117
74052-339-55Hygenize Hand Sanitizer208198 mL in 1 BOTTLE, PUMPGEL20819817
74052-339-97Hygenize Hand Sanitizer4 in 1 CARTONGEL417
74052-339-99Hygenize Hand Sanitizer1041000 mL in 1 BOTTLE, PUMPGEL104100017
74052-340-04Hygenize118 mL in 1 BOTTLE, SPRAYLIQUID11817
74052-341-01Hand Sanitizer IPA Gel3785.41 mL in 1 BOTTLE, PUMPGEL3785.4117
74052-341-32Hand Sanitizer IPA Gel946.353 mL in 1 BOTTLE, PUMPGEL946.35317
74052-341-33Hand Sanitizer IPA Gel6 in 1 CARTONGEL617
74052-341-99Hand Sanitizer IPA Gel4 in 1 CARTONGEL417

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74052-337HYGENIZE HAND SANITIZER (ALCOHOL) GEL IRIS HAND SANITIZER GEL (ALCOHOL) GEL HYGENIZE (ALCOHOL) LIQUID HAND SANITIZER IPA GEL (ISOPROPYL ALCOHOL) GEL [IRIS LLC]17Legacy NDC, 14 package rows20201004_a2677c78-958b-3b1a-e053-2995a90a6ae0.zip
74052-339HYGENIZE HAND SANITIZER (ALCOHOL) GEL IRIS HAND SANITIZER GEL (ALCOHOL) GEL HYGENIZE (ALCOHOL) LIQUID HAND SANITIZER IPA GEL (ISOPROPYL ALCOHOL) GEL [IRIS LLC]17Legacy NDC, 15 package rows20201004_a2677c78-958b-3b1a-e053-2995a90a6ae0.zip
74052-340HYGENIZE HAND SANITIZER (ALCOHOL) GEL IRIS HAND SANITIZER GEL (ALCOHOL) GEL HYGENIZE (ALCOHOL) LIQUID HAND SANITIZER IPA GEL (ISOPROPYL ALCOHOL) GEL [IRIS LLC]17Legacy NDC, 1 package rows20201004_a2677c78-958b-3b1a-e053-2995a90a6ae0.zip
74052-341HYGENIZE HAND SANITIZER (ALCOHOL) GEL IRIS HAND SANITIZER GEL (ALCOHOL) GEL HYGENIZE (ALCOHOL) LIQUID HAND SANITIZER IPA GEL (ISOPROPYL ALCOHOL) GEL [IRIS LLC]174 package rows20201004_a2677c78-958b-3b1a-e053-2995a90a6ae0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74052-33974052-339-10, 74052-339-02, 74052-339-04, 74052-339-08, 74052-339-12, 74052-339-16, 74052-339-28, 74052-339-38, 74052-339-55, 74052-339-99, 74052-339-32, 74052-339-33, 74052-339-34, 74052-339-01, 74052-339-97
74052-33774052-337-10, 74052-337-02, 74052-337-04, 74052-337-08, 74052-337-12, 74052-337-16, 74052-337-28, 74052-337-38, 74052-337-55, 74052-337-99, 74052-337-01, 74052-337-03, 74052-337-34, 74052-337-17
74052-34074052-340-04
74052-34174052-341-32, 74052-341-33, 74052-341-01, 74052-341-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML · Source PDF

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
b0cf3bd5-4a79-549b-e053-2995a90ab082a2677c78-958b-3b1a-e053-2995a90a6ae02020-10-03WarningsExact identifier
spl id: b0cf3bd5-4a79-549b-e053-2995a90ab082
spl set id: a2677c78-958b-3b1a-e053-2995a90a6ae0

Reported adverse events (FAERS/openFDA)#

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