FDA.reportPublic FDA data

Iris Hand Sanitizer

Manufacturer
Iris LLC
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:15:52

Label at a glance#

ProductIris Hand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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.
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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front label 237 mlFront label 237 mlReal label directionsReal label directions237 mL NDC: 74052-338-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN10
1241663ethanol 0.8 ML/ML Topical SpraySCD10
1241663ethanol 80 % Topical SpraySY10

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
74052-338-012022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-022022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-032022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-042022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-082022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-102022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-122022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-162022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-172022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-282022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-342022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-382022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-552022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb
74052-338-992022-01-28C16284748780-1d6a99b39-c26a-a426-e053-dadaa90af4c2a24362d0-fef7-10a8-e053-2995a90a77bb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74052-338-01Iris Hand Sanitizer30 mL in 1 BOTTLESPRAY3010
74052-338-02Iris Hand Sanitizer59 mL in 1 BOTTLESPRAY5910
74052-338-03Iris Hand Sanitizer100 mL in 1 BOTTLESPRAY10010
74052-338-04Iris Hand Sanitizer118 mL in 1 BOTTLESPRAY11810
74052-338-08Iris Hand Sanitizer237 mL in 1 BOTTLESPRAY23710
74052-338-10Iris Hand Sanitizer296 mL in 1 BOTTLESPRAY29610
74052-338-12Iris Hand Sanitizer355 mL in 1 BOTTLESPRAY35510
74052-338-16Iris Hand Sanitizer473 mL in 1 BOTTLESPRAY47310
74052-338-17Iris Hand Sanitizer500 mL in 1 BOTTLESPRAY50010
74052-338-28Iris Hand Sanitizer3785.41 mL in 1 BOTTLESPRAY3785.4110
74052-338-34Iris Hand Sanitizer1000 mL in 1 BOTTLESPRAY100010
74052-338-38Iris Hand Sanitizer18927.1 mL in 1 BOTTLESPRAY18927.110
74052-338-55Iris Hand Sanitizer208198 mL in 1 BOTTLESPRAY20819810
74052-338-99Iris Hand Sanitizer1041000 mL in 1 BOTTLESPRAY104100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74052-338IRIS HAND SANITIZER (ALCOHOL) SPRAY [IRIS LLC]10Legacy NDC, 14 package rows20200604_a24362d0-fef7-10a8-e053-2995a90a77bb.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
74052-33874052-338-10, 74052-338-02, 74052-338-04, 74052-338-08, 74052-338-12, 74052-338-16, 74052-338-28, 74052-338-38, 74052-338-55, 74052-338-99, 74052-338-01, 74052-338-03, 74052-338-34, 74052-338-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a72212ac-be04-0f82-e053-2a95a90a9a3ca24362d0-fef7-10a8-e053-2995a90a77bb2020-06-02WarningsExact identifier
spl id: a72212ac-be04-0f82-e053-2a95a90a9a3c
spl set id: a24362d0-fef7-10a8-e053-2995a90a77bb

Reported adverse events (FAERS/openFDA)#

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