FDA.reportPublic FDA data

PUROMA Hand sanitizer

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:14

Label at a glance#

ProductPUROMA Hand sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

Spray enough product on hands to cover all surfaces. Rub hands together briskly until dry.

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.
  • When using this product do not use in or near theeyes. In case of contact, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or rash appears and lasts.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

Directions

DOSAGE & ADMINISTRATION SECTION

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-003-012025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-022025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-032025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-042025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-052025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-062025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-072025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-082025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-092025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-102025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer
80948-003-112025-01-30C16284748780-12cef2736-8f63-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 75% hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-003-01PUROMA Hand sanitizer30 mL in 1 BOTTLELIQUID304
80948-003-02PUROMA Hand sanitizer60 mL in 1 BOTTLELIQUID604
80948-003-03PUROMA Hand sanitizer50 mL in 1 BOTTLELIQUID504
80948-003-04PUROMA Hand sanitizer100 mL in 1 BOTTLELIQUID1004
80948-003-05PUROMA Hand sanitizer200 mL in 1 BOTTLELIQUID2004
80948-003-06PUROMA Hand sanitizer250 mL in 1 BOTTLELIQUID2504
80948-003-07PUROMA Hand sanitizer500 mL in 1 BOTTLELIQUID5004
80948-003-08PUROMA Hand sanitizer1000 mL in 1 BOTTLELIQUID10004
80948-003-09PUROMA Hand sanitizer5000 mL in 1 CANLIQUID50004
80948-003-10PUROMA Hand sanitizer50 mL in 1 BOTTLELIQUID504
80948-003-10PUROMA Hand sanitizer12 in 1 PACKAGELIQUID124
80948-003-11PUROMA Hand sanitizer100 mL in 1 BOTTLELIQUID1004
80948-003-11PUROMA Hand sanitizer6 in 1 PACKAGELIQUID64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-003PUROMA HAND SANITIZER (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 13 package rows20231214_7c76cf3c-443d-4918-b12a-869ff665e229.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
80948-00380948-003-01, 80948-003-02, 80948-003-03, 80948-003-04, 80948-003-05, 80948-003-06, 80948-003-07, 80948-003-08, 80948-003-09, 80948-003-10, 80948-003-11

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
0c6a56f2-31ff-f4b8-e063-6394a90a788f7c76cf3c-443d-4918-b12a-869ff665e2292023-12-13WarningsExact identifier
spl id: 0c6a56f2-31ff-f4b8-e063-6394a90a788f
spl set id: 7c76cf3c-443d-4918-b12a-869ff665e229

Reported adverse events (FAERS/openFDA)#

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