FDA.reportPublic FDA data

Cleands Hand Sanitizer

Manufacturer
Refrimed, S.A. de C.V.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:18:05

Label at a glance#

ProductCleands Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions • 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cleands® Hand Sanitizer

Drug Facts

Active ingredient

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.

Keep the product away from sunlight.

Do not use

OTC - DO NOT USE SECTION

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product

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. If symptoms persist call your doctor.

Keep out of reach of children

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

Directions

• 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Carbomer,Glycerine, Fragrance, Triethanolamine

Other information

SPL UNCLASSIFIED SECTION

Other information

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabelLabelLabelLabelLabel

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78264-101-102022-01-28C16284748780-1d6a99b39-8e66-a426-e053-dadaa90af4c2Cleands ® Hand Sanitizer
78264-101-252022-01-28C16284748780-1d6a99b39-8e66-a426-e053-dadaa90af4c2Cleands ® Hand Sanitizer
78264-101-302022-01-28C16284748780-1d6a99b39-8e66-a426-e053-dadaa90af4c2Cleands ® Hand Sanitizer
78264-101-502022-01-28C16284748780-1d6a99b39-8e66-a426-e053-dadaa90af4c2Cleands ® Hand Sanitizer
78264-101-602022-01-28C16284748780-1d6a99b39-8e66-a426-e053-dadaa90af4c2Cleands ® Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78264-101-10Cleands Hand Sanitizer1000 mL in 1 BOTTLEGEL10007
78264-101-25Cleands Hand Sanitizer250 mL in 1 BOTTLEGEL2507
78264-101-30Cleands Hand Sanitizer30 mL in 1 BOTTLEGEL307
78264-101-50Cleands Hand Sanitizer500 mL in 1 BOTTLEGEL5007
78264-101-60Cleands Hand Sanitizer60 mL in 1 BOTTLEGEL607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78264-101CLEANDS HAND SANITIZER (ALCOHOL) GEL [REFRIMED, S.A. DE C.V.]7Legacy NDC, 5 package rows20200618_a620073c-4110-c539-e053-2995a90adae2.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78264-10178264-101-25, 78264-101-50, 78264-101-10, 78264-101-60, 78264-101-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
a84f650f-d900-184c-e053-2a95a90a575da620073c-4110-c539-e053-2995a90adae22020-06-17WarningsExact identifier
spl id: a84f650f-d900-184c-e053-2a95a90a575d
spl set id: a620073c-4110-c539-e053-2995a90adae2

Reported adverse events (FAERS/openFDA)#

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