FDA.reportPublic FDA data

PUROMA

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:14

Label at a glance#

ProductPUROMA
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol  70% 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

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 (430°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, ISOPROPYL ALCOHOL ,GLYCERIN, ISOPROPYL MYRISTATE,ALPHA.-TOCOPHEROL ACETATE, CARBOMER HOMOPOLYMER , CAPRYLYL GLYCOL,AMINOMETHYLPROPANOL, 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
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-002-012025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-022025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-032025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-042025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-052025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-062025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-072025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-082025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-092025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-102025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-112025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-122025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-132025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-142025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-152025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-162025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-172025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-002-01PUROMA30 mL in 1 BOTTLEGEL305
80948-002-02PUROMA60 mL in 1 BOTTLEGEL605
80948-002-03PUROMA50 mL in 1 BOTTLEGEL505
80948-002-04PUROMA100 mL in 1 BOTTLEGEL1005
80948-002-05PUROMA120 mL in 1 BOTTLEGEL1205
80948-002-06PUROMA320 mL in 1 BOTTLEGEL3205
80948-002-07PUROMA503 mL in 1 BOTTLEGEL5035
80948-002-08PUROMA5000 mL in 1 CANGEL50005
80948-002-09PUROMA50000 mL in 1 CANGEL500005
80948-002-10PUROMA200000 mL in 1 DRUMGEL2000005
80948-002-11PUROMA30 mL in 1 BOTTLEGEL305
80948-002-11PUROMA12 in 1 PACKAGEGEL125
80948-002-12PUROMA6 in 1 PACKAGEGEL65
80948-002-12PUROMA60 mL in 1 BOTTLEGEL605
80948-002-13PUROMA4 in 1 PACKAGEGEL45
80948-002-13PUROMA237 mL in 1 BOTTLEGEL2375
80948-002-14PUROMA237 mL in 1 BOTTLEGEL2375
80948-002-15PUROMA488 mL in 1 BOTTLEGEL4885
80948-002-16PUROMA488 mL in 1 BOTTLEGEL4885
80948-002-16PUROMA2 in 1 PACKAGEGEL25
80948-002-17PUROMA947 mL in 1 BOTTLEGEL9475

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-002PUROMA (ALCOHOL) GEL [ZENITH MICRO CONTROL]5Legacy NDC, 21 package rows20231214_8825ca11-1e99-491f-9dfc-a282ded85c96.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-00280948-002-01, 80948-002-02, 80948-002-03, 80948-002-04, 80948-002-05, 80948-002-06, 80948-002-07, 80948-002-08, 80948-002-09, 80948-002-10, 80948-002-11, 80948-002-12, 80948-002-13, 80948-002-14, 80948-002-15, 80948-002-16, 80948-002-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
0c6a2e89-2ce7-b52d-e063-6294a90a86598825ca11-1e99-491f-9dfc-a282ded85c962023-12-13WarningsExact identifier
spl id: 0c6a2e89-2ce7-b52d-e063-6294a90a8659
spl set id: 8825ca11-1e99-491f-9dfc-a282ded85c96

Reported adverse events (FAERS/openFDA)#

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