FDA.reportPublic FDA data

PUROMA Antibacterial Hand Wash Fragrance Free

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:19

Label at a glance#

ProductPUROMA Antibacterial Hand Wash Fragrance Free
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

• Wet hands and wrists with clean running water • Apply appropriate amount of product • Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly • Rinse thoroughly with running water • Dry hands completely.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

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 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands and wrists with clean running water
• Apply appropriate amount of product
• Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly
• Rinse thoroughly with running water
• Dry hands completely.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Sodium Chloride, Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Glycol Distearate, Polysorbate 20.

Other information

SPL UNCLASSIFIED SECTION

• Store below 104°F (40°C)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-006-012025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-022025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-032025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-042025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-052025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-062025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-072025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-082025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-092025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-102025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-112025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-122025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-132025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-142025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-152025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-162025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-172025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-182025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-192025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-202025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-212025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-222025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-232025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-242025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-252025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-262025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-272025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-282025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-292025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-302025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-312025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-322025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-332025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-342025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-352025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-362025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-372025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b
80948-006-382025-01-30C16284748780-12cef2736-9ef2-d83d-e063-dadaa90ab31f35f2dec6-2f9b-408b-84c2-06c76eae2d3b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-006-01PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-01PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-02PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-02PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-03PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-03PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-04PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-04PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-05PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 PACKAGELIQUID1784
80948-006-05PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-06PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-06PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-07PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-07PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-08PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-08PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-09PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-09PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-10PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-10PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-11PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-11PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-12PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-12PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-13PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-13PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-14PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-14PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-15PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-15PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-16PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-16PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-17PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-17PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-18PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-18PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-19PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-19PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-20PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-20PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-21PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-21PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-22PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-22PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-23PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-23PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-24PUROMA Antibacterial Hand Wash Fragrance Free947 mL in 1 BOTTLELIQUID9474
80948-006-24PUROMA Antibacterial Hand Wash Fragrance Free2 in 1 PACKAGELIQUID24
80948-006-25PUROMA Antibacterial Hand Wash Fragrance Free947 mL in 1 BOTTLELIQUID9474
80948-006-25PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-26PUROMA Antibacterial Hand Wash Fragrance Free5000 mL in 1 CANLIQUID50004
80948-006-27PUROMA Antibacterial Hand Wash Fragrance Free50000 mL in 1 CANLIQUID500004
80948-006-28PUROMA Antibacterial Hand Wash Fragrance Free200000 mL in 1 DRUMLIQUID2000004
80948-006-29PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-29PUROMA Antibacterial Hand Wash Fragrance Free4 in 1 PACKAGELIQUID44
80948-006-30PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-30PUROMA Antibacterial Hand Wash Fragrance Free6 in 1 PACKAGELIQUID64
80948-006-31PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-31PUROMA Antibacterial Hand Wash Fragrance Free8 in 1 PACKAGELIQUID84
80948-006-32PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-32PUROMA Antibacterial Hand Wash Fragrance Free12 in 1 PACKAGELIQUID124
80948-006-33PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-33PUROMA Antibacterial Hand Wash Fragrance Free24 in 1 PACKAGELIQUID244
80948-006-34PUROMA Antibacterial Hand Wash Fragrance Free178 mL in 1 BOTTLELIQUID1784
80948-006-35PUROMA Antibacterial Hand Wash Fragrance Free237 mL in 1 BOTTLELIQUID2374
80948-006-36PUROMA Antibacterial Hand Wash Fragrance Free326 mL in 1 BOTTLELIQUID3264
80948-006-37PUROMA Antibacterial Hand Wash Fragrance Free474 mL in 1 BOTTLELIQUID4744
80948-006-38PUROMA Antibacterial Hand Wash Fragrance Free974 mL in 1 BOTTLELIQUID9744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-006PUROMA ANTIBACTERIAL HAND WASH FRAGRANCE FREE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 68 package rows20231215_35f2dec6-2f9b-408b-84c2-06c76eae2d3b.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-00680948-006-01, 80948-006-02, 80948-006-03, 80948-006-04, 80948-006-05, 80948-006-06, 80948-006-07, 80948-006-08, 80948-006-09, 80948-006-10, 80948-006-11, 80948-006-12, 80948-006-13, 80948-006-14, 80948-006-15, 80948-006-16, 80948-006-17, 80948-006-18, 80948-006-19, 80948-006-20, 80948-006-21, 80948-006-22, 80948-006-23, 80948-006-24, 80948-006-25, 80948-006-26, 80948-006-27, 80948-006-28, 80948-006-29, 80948-006-30, 80948-006-31, 80948-006-32, 80948-006-33, 80948-006-34, 80948-006-35, 80948-006-36, 80948-006-37, 80948-006-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
GLYCERINPDC6A3C0OXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM CHLORIDE451W47IQ8XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
GLYCOL DISTEARATE13W7MDN21WIACT
POLYSORBATE 207T1F30V5YHIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
0c774d61-cc66-dc9f-e063-6394a90a625835f2dec6-2f9b-408b-84c2-06c76eae2d3b2023-12-14WarningsExact identifier
spl id: 0c774d61-cc66-dc9f-e063-6394a90a6258
spl set id: 35f2dec6-2f9b-408b-84c2-06c76eae2d3b

Reported adverse events (FAERS/openFDA)#

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