FDA.reportPublic FDA data

PUROMA Alcohol 75% Hand Sanitizer Wipe

Manufacturer
ZENITH MICRO CONTROL
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:12

Label at a glance#

ProductPUROMA Alcohol 75% Hand Sanitizer Wipe
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

• Wet hands thoroughly with product and allow to dry. • Discard wipe in trash receptacle after use. Do not flush • Children under 6 years of age should be supervised when using Puroma Hand Sanitizer wipe.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

Warnings 

WARNINGS SECTION

• For external use only.
• When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
• Stop use and ask a doctor ifirritation or rash appears and lasts.

Keep out of reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands thoroughly with product and allow to dry.
• Discard wipe in trash receptacle after use. Do not flush
• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer wipe.

Other information 

SPL UNCLASSIFIED SECTION

Store below 104°F (40°C).
May discolor certain fabrics or surfaces

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN4
1307051ethanol 0.75 ML/ML Medicated PadSCD4
1307051ethanol 75 % Hand Sanitizer WipesSY4
1307051ethyl alcohol 75 % Topical ClothSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-013-012025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-022025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-032025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-042025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-052025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-062025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-072025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-082025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-092025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-102025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-112025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-122025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-132025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-142025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-152025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-162025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-172025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-182025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-202025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-212025-07-29C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-012024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-022024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-032024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-042024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-052024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-062024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-072024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-082024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-092024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-102024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-112024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-122024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-132024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-142024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-152024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-162024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-172024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-182024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-202024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-212024-02-01C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-012023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-022023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-032023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-042023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-052023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-062023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-072023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-082023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-092023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-102023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-112023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-122023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-132023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-142023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-152023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-162023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-172023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-182023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-202023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17
80948-013-212023-01-30C16284748780-1f386c64a-074b-0266-e053-dadaa90a7c1a751f3514-cea9-4d82-b58b-f51225db9b17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-013-01PUROMA Alcohol 75% Hand Sanitizer Wipe66 mL in 1 PACKAGECLOTH664
80948-013-01PUROMA Alcohol 75% Hand Sanitizer Wipe10 in 1 PACKAGECLOTH104
80948-013-02PUROMA Alcohol 75% Hand Sanitizer Wipe20 in 1 PACKAGECLOTH204
80948-013-02PUROMA Alcohol 75% Hand Sanitizer Wipe132 mL in 1 PACKAGECLOTH1324
80948-013-03PUROMA Alcohol 75% Hand Sanitizer Wipe40 in 1 PACKAGECLOTH404
80948-013-03PUROMA Alcohol 75% Hand Sanitizer Wipe264 mL in 1 PACKAGECLOTH2644
80948-013-04PUROMA Alcohol 75% Hand Sanitizer Wipe528 mL in 1 PACKAGECLOTH5284
80948-013-04PUROMA Alcohol 75% Hand Sanitizer Wipe80 in 1 PACKAGECLOTH804
80948-013-05PUROMA Alcohol 75% Hand Sanitizer Wipe120 in 1 PACKAGECLOTH1204
80948-013-05PUROMA Alcohol 75% Hand Sanitizer Wipe792 mL in 1 PACKAGECLOTH7924
80948-013-06PUROMA Alcohol 75% Hand Sanitizer Wipe350 mL in 1 PACKAGECLOTH3504
80948-013-06PUROMA Alcohol 75% Hand Sanitizer Wipe50 in 1 CANISTERCLOTH504
80948-013-07PUROMA Alcohol 75% Hand Sanitizer Wipe80 in 1 CANISTERCLOTH804
80948-013-07PUROMA Alcohol 75% Hand Sanitizer Wipe560 mL in 1 PACKAGECLOTH5604
80948-013-08PUROMA Alcohol 75% Hand Sanitizer Wipe700 mL in 1 CANISTERCLOTH7004
80948-013-08PUROMA Alcohol 75% Hand Sanitizer Wipe100 in 1 CANISTERCLOTH1004
80948-013-09PUROMA Alcohol 75% Hand Sanitizer Wipe120 in 1 CANISTERCLOTH1204
80948-013-09PUROMA Alcohol 75% Hand Sanitizer Wipe840 mL in 1 CANISTERCLOTH8404
80948-013-10PUROMA Alcohol 75% Hand Sanitizer Wipe10 in 1 POUCHCLOTH104
80948-013-10PUROMA Alcohol 75% Hand Sanitizer Wipe66 mL in 1 POUCHCLOTH664
80948-013-11PUROMA Alcohol 75% Hand Sanitizer Wipe132 mL in 1 POUCHCLOTH1324
80948-013-11PUROMA Alcohol 75% Hand Sanitizer Wipe20 in 1 POUCHCLOTH204
80948-013-12PUROMA Alcohol 75% Hand Sanitizer Wipe264 mL in 1 POUCHCLOTH2644
80948-013-12PUROMA Alcohol 75% Hand Sanitizer Wipe40 in 1 POUCHCLOTH404
80948-013-13PUROMA Alcohol 75% Hand Sanitizer Wipe80 in 1 POUCHCLOTH804
80948-013-13PUROMA Alcohol 75% Hand Sanitizer Wipe528 mL in 1 POUCHCLOTH5284
80948-013-14PUROMA Alcohol 75% Hand Sanitizer Wipe792 mL in 1 POUCHCLOTH7924
80948-013-14PUROMA Alcohol 75% Hand Sanitizer Wipe120 in 1 POUCHCLOTH1204
80948-013-15PUROMA Alcohol 75% Hand Sanitizer Wipe330 mL in 1 CANISTERCLOTH3304
80948-013-15PUROMA Alcohol 75% Hand Sanitizer Wipe50 in 1 CANISTERCLOTH504
80948-013-16PUROMA Alcohol 75% Hand Sanitizer Wipe528 mL in 1 CANISTERCLOTH5284
80948-013-16PUROMA Alcohol 75% Hand Sanitizer Wipe80 in 1 CANISTERCLOTH804
80948-013-17PUROMA Alcohol 75% Hand Sanitizer Wipe100 in 1 CANISTERCLOTH1004
80948-013-17PUROMA Alcohol 75% Hand Sanitizer Wipe660 mL in 1 CANISTERCLOTH6604
80948-013-18PUROMA Alcohol 75% Hand Sanitizer Wipe120 in 1 CANISTERCLOTH1204
80948-013-18PUROMA Alcohol 75% Hand Sanitizer Wipe792 mL in 1 CANISTERCLOTH7924
80948-013-20PUROMA Alcohol 75% Hand Sanitizer Wipe6.6 mL in 1 PACKETCLOTH6.64
80948-013-20PUROMA Alcohol 75% Hand Sanitizer Wipe1 in 1 PACKETCLOTH14
80948-013-21PUROMA Alcohol 75% Hand Sanitizer Wipe25 in 1 BOXCLOTH254
80948-013-21PUROMA Alcohol 75% Hand Sanitizer Wipe165 mL in 1 PACKETCLOTH1654

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-013PUROMA ALCOHOL 75% HAND SANITIZER WIPE (ALCOHOL) CLOTH [ZENITH MICRO CONTROL]4Legacy NDC, 40 package rows20240202_751f3514-cea9-4d82-b58b-f51225db9b17.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-01380948-013-01, 80948-013-02, 80948-013-03, 80948-013-04, 80948-013-05, 80948-013-06, 80948-013-07, 80948-013-08, 80948-013-09, 80948-013-10, 80948-013-11, 80948-013-12, 80948-013-13, 80948-013-14, 80948-013-15, 80948-013-16, 80948-013-17, 80948-013-18, 80948-013-20, 80948-013-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
10584ca9-6199-4545-e063-6394a90aba44751f3514-cea9-4d82-b58b-f51225db9b172024-02-01WarningsExact identifier
spl id: 10584ca9-6199-4545-e063-6394a90aba44
spl set id: 751f3514-cea9-4d82-b58b-f51225db9b17

Reported adverse events (FAERS/openFDA)#

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