FDA.reportPublic FDA data

CUIR Hand Sanitizer

Manufacturer
Comercial Riley S.A. de C.V.
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:30

Label at a glance#

ProductCUIR Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when water soap & towel are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children less than 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease.
  • For use when water soap & towel are not available.

Warnings

WARNINGS SECTION

Flammable, Keep away from heat or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • In or near the eyes. In case of contact, rinse eyes thoroughly with water.
  • On children less than 2 months of age.
  • On open skin wounds.

Stop use and ask a physician,

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Supervise children less than 6 years of age when using this product to avoid swallowing.
If swallowed, get medical help or contact a Poison Control Center right away.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydrogen peroxide, purified water (USP)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78514-001-162024-01-30C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer
78514-001-332024-01-30C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer
78514-001-162022-02-25C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer
78514-001-332022-02-25C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer
78514-001-162022-01-28C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer
78514-001-332022-01-28C16284748780-1d6a99b39-e012-a426-e053-dadaa90af4c2CUIR Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78514-001-16CUIR Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78514-001-33CUIR Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78514-001CUIR HAND SANITIZER (ALCOHOL) GEL [COMERCIAL RILEY S.A. DE C.V.]2Legacy NDC, 2 package rows20220226_0ef861b1-dcac-4c0b-bbc9-4ca7fedbf37e.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
78514-00178514-001-33, 78514-001-16

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

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
d8d935bd-691e-c427-e053-2a95a90a5da80ef861b1-dcac-4c0b-bbc9-4ca7fedbf37e2022-02-25WarningsExact identifier
spl id: d8d935bd-691e-c427-e053-2a95a90a5da8
spl set id: 0ef861b1-dcac-4c0b-bbc9-4ca7fedbf37e

Reported adverse events (FAERS/openFDA)#

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