FDA.reportPublic FDA data

PUROMA

Manufacturer
ZENITH MICRO CONTROL
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:08:12

Label at a glance#

ProductPUROMA
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

Alcohol 75% V/V

Purpose

OTC - PURPOSE SECTION

Antiseptic.

Warnings

WARNINGS SECTION

  • Flammable. Keep away from fire or flame.

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.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

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.

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.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER,ISOPROPYL ALCOHOL ,GLYCERIN, ISOPROPYL MYRISTATE, ALPHA.-TOCOPHEROL ACETATE , CAPRYLYL GLYCOL, ALOE VERA LEAF, PROPYLENE GLYCOL, COCO-CAPRYLATE , FRAGRANCE

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN7
1307051ethanol 0.75 ML/ML Medicated PadSCD7
1307051ethanol 75 % Hand Sanitizer WipesSY7
1307051ethyl alcohol 75 % Topical ClothSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-001-012025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142025-07-29C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-012024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142024-02-01C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-012024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142024-01-30C16284748780-11030e365-3f0e-111a-e063-dadaa90a10e2PUROMA Ethyl Alcohol 75% Antiseptic wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-001-01PUROMA66 mL in 1 PACKAGECLOTH667
80948-001-01PUROMA10 in 1 PACKAGECLOTH107
80948-001-02PUROMA20 in 1 PACKAGECLOTH207
80948-001-02PUROMA132 mL in 1 PACKAGECLOTH1327
80948-001-03PUROMA40 in 1 PACKAGECLOTH407
80948-001-03PUROMA264 mL in 1 PACKAGECLOTH2647
80948-001-04PUROMA528 mL in 1 PACKAGECLOTH5287
80948-001-04PUROMA80 in 1 PACKAGECLOTH807
80948-001-05PUROMA120 in 1 PACKAGECLOTH1207
80948-001-05PUROMA792 mL in 1 PACKAGECLOTH7927
80948-001-06PUROMA50 in 1 CANISTERCLOTH507
80948-001-06PUROMA350 mL in 1 CANISTERCLOTH3507
80948-001-07PUROMA700 mL in 1 CANISTERCLOTH7007
80948-001-07PUROMA100 in 1 CANISTERCLOTH1007
80948-001-08PUROMA10 in 1 POUCHCLOTH107
80948-001-08PUROMA66 mL in 1 POUCHCLOTH667
80948-001-09PUROMA20 in 1 POUCHCLOTH207
80948-001-09PUROMA132 mL in 1 POUCHCLOTH1327
80948-001-10PUROMA264 mL in 1 POUCHCLOTH2647
80948-001-10PUROMA40 in 1 POUCHCLOTH407
80948-001-11PUROMA80 in 1 CANISTERCLOTH807
80948-001-11PUROMA528 mL in 1 CANISTERCLOTH5287
80948-001-12PUROMA792 mL in 1 CANISTERCLOTH7927
80948-001-12PUROMA120 in 1 CANISTERCLOTH1207
80948-001-13PUROMA330 mL in 1 CANISTERCLOTH3307
80948-001-13PUROMA50 in 1 CANISTERCLOTH507
80948-001-14PUROMA660 mL in 1 CANISTERCLOTH6607
80948-001-14PUROMA100 in 1 CANISTERCLOTH1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-001PUROMA (ALCOHOL) CLOTH [ZENITH MICRO CONTROL]7Legacy NDC, 28 package rows20240202_a7e47230-7007-40e5-9214-1f6f6c77d221.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-00180948-001-01, 80948-001-02, 80948-001-03, 80948-001-04, 80948-001-05, 80948-001-06, 80948-001-07, 80948-001-08, 80948-001-09, 80948-001-10, 80948-001-11, 80948-001-12, 80948-001-13, 80948-001-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCO-CAPRYLATE4828G836N6IACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
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
10582bc7-e14f-40dd-e063-6394a90ae3cca7e47230-7007-40e5-9214-1f6f6c77d2212024-02-01WarningsExact identifier
spl id: 10582bc7-e14f-40dd-e063-6394a90ae3cc
spl set id: a7e47230-7007-40e5-9214-1f6f6c77d221

Reported adverse events (FAERS/openFDA)#

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