FDA.reportPublic FDA data

Eyefull PCD Kit

Manufacturer
Rafac International Inc
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:32

Label at a glance#

ProductEyefull PCD Kit
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry. Discard in trash receptacle after use. Do not flush.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria that potentially 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash occurs. These may be signs of a serious condition.

Do not use 

OTC - DO NOT USE SECTION

  • On children of less than 5 year of age.
  • On open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.
  • Discard in trash receptacle after use.
  • Do not flush.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP

Package Labeling:80184-999-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelBottleBottle

Package Labeling:  80184-996-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2BoxBox

80184-997-14 Blue Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blue KitBlue Kit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1305100ethanol 75 % Topical GelPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1305100ethanol 75 % Topical GelSY1
1307051ethyl alcohol 75 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80184-997-142022-01-28C16284748780-1d6a99b39-4603-a426-e053-dadaa90af4c2Eyefull PCD Kit (Blue)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80184-996-10Eyefull PCD Kit20 in 1 BAGCLOTH0.75 mL in 1mL1
80184-996-10Eyefull PCD Kit3.5 mL in 1 PATCHCLOTH3.5 mL0.75 mL in 1mL1
80184-997-14Eyefull PCD Kit1 in 1 KITKIT11
80184-999-10Eyefull PCD Kit100 mL in 1 BOTTLEGEL100 mL0.75 mL in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80184-996EYEFULL PCD KIT (ALCOHOL) KIT [RAFAC INTERNATIONAL INC]1Unmatched20200902_9eab0695-5cf9-40a1-b84c-4d6302b5e2ac.zip
80184-997EYEFULL PCD KIT (ALCOHOL) KIT [RAFAC INTERNATIONAL INC]1Legacy NDC, 4 package rows20200902_9eab0695-5cf9-40a1-b84c-4d6302b5e2ac.zip
80184-999EYEFULL PCD KIT (ALCOHOL) KIT [RAFAC INTERNATIONAL INC]1Unmatched20200902_9eab0695-5cf9-40a1-b84c-4d6302b5e2ac.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
80184-99780184-997-14
80184-99980184-999-10
80184-99680184-996-10

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
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
ae3159f3-29f4-8cb6-e053-2995a90a98de9eab0695-5cf9-40a1-b84c-4d6302b5e2ac2020-08-31WarningsExact identifier
spl id: ae3159f3-29f4-8cb6-e053-2995a90a98de
spl set id: 9eab0695-5cf9-40a1-b84c-4d6302b5e2ac

Reported adverse events (FAERS/openFDA)#

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