FDA.reportPublic FDA data

PUROMA Hand Sanitizer Fragrance Free

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:26

Label at a glance#

ProductPUROMA Hand Sanitizer Fragrance Free
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

Ethyl alcohol 70% V/V

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

   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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aminomethylpropanol, Aloe Vera Leaf, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Alpha.-Tocopherol Acetate , Carbomer Homopolymer , Caprylyl Glycol, Coco Caprylate. Glyceryl Oleate, PEG-7 Glyceryl Cocoate, Propylene Glycol.

Other information

SPL UNCLASSIFIED SECTION

• Store below 110°F (430°C)
• May discolor certain fabrics or surfaces

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-009-012025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-022025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-032025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-042025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-052025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-062025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-072025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-082025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-092025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-102025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-112025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-122025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-132025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-142025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-152025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-162025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-172025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-182025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-192025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-202025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-212025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-222025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-232025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-242025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-252025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-262025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-272025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-282025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-292025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-302025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-312025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-322025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-332025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-342025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-352025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-362025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-372025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-382025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-392025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb
80948-009-402025-01-30C16284748780-12cef2736-a0ba-d83d-e063-dadaa90ab31fbeb3ff90-f8de-00d1-e053-2a95a90a6fdb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-009-01PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-01PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-02PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-02PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-03PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-03PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-04PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-009-04PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-05PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-05PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-06PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-06PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-07PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-07PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-08PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-08PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-09PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-09PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-10PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-10PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-11PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-11PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-12PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-12PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-13PUROMA Hand Sanitizer Fragrance Free89 mL in 1 BOTTLELIQUID893
80948-009-13PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-14PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-14PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-15PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-15PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-16PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-16PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-17PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-17PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-18PUROMA Hand Sanitizer Fragrance Free178 mL in 1 BOTTLELIQUID1783
80948-009-18PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-19PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-19PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-20PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-20PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-21PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-21PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-22PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-22PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-23PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-23PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-24PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-24PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-25PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-25PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-009-26PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-26PUROMA Hand Sanitizer Fragrance Free326 mL in 1 BOTTLELIQUID3263
80948-009-27PUROMA Hand Sanitizer Fragrance Free488 mL in 1 BOTTLELIQUID4883
80948-009-27PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-28PUROMA Hand Sanitizer Fragrance Free947 mL in 1 BOTTLELIQUID9473
80948-009-28PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-009-29PUROMA Hand Sanitizer Fragrance Free5000 mL in 1 CANLIQUID50003
80948-009-30PUROMA Hand Sanitizer Fragrance Free50000 mL in 1 CANLIQUID500003
80948-009-31PUROMA Hand Sanitizer Fragrance Free200000 mL in 1 DRUMLIQUID2000003
80948-009-32PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-32PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-009-33PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-33PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-009-34PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-34PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-009-35PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-35PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-009-36PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-009-37PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-009-38PUROMA Hand Sanitizer Fragrance Free237 mL in 1 BOTTLELIQUID2373
80948-009-39PUROMA Hand Sanitizer Fragrance Free488 mL in 1 BOTTLELIQUID4883
80948-009-40PUROMA Hand Sanitizer Fragrance Free947 mL in 1 BOTTLELIQUID9473

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-009PUROMA HAND SANITIZER FRAGRANCE FREE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 72 package rows20231215_beb3ff90-f8de-00d1-e053-2a95a90a6fdb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-00980948-009-01, 80948-009-02, 80948-009-03, 80948-009-04, 80948-009-05, 80948-009-06, 80948-009-07, 80948-009-08, 80948-009-09, 80948-009-10, 80948-009-11, 80948-009-12, 80948-009-13, 80948-009-14, 80948-009-15, 80948-009-16, 80948-009-17, 80948-009-18, 80948-009-19, 80948-009-20, 80948-009-21, 80948-009-22, 80948-009-23, 80948-009-24, 80948-009-25, 80948-009-26, 80948-009-27, 80948-009-28, 80948-009-29, 80948-009-30, 80948-009-31, 80948-009-32, 80948-009-33, 80948-009-34, 80948-009-35, 80948-009-36, 80948-009-37, 80948-009-38, 80948-009-39, 80948-009-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
GLYCERYL OLEATE4PC054V79PIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
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
0c778bde-ae9b-f219-e063-6394a90a24edbeb3ff90-f8de-00d1-e053-2a95a90a6fdb2023-12-14WarningsExact identifier
spl id: 0c778bde-ae9b-f219-e063-6394a90a24ed
spl set id: beb3ff90-f8de-00d1-e053-2a95a90a6fdb

Reported adverse events (FAERS/openFDA)#

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