FDA.reportPublic FDA data

PUROMA Antibacterial Hand Wash with Fragrance Lavender rose

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 00:04:24

Label at a glance#

ProductPUROMA Antibacterial Hand Wash with Fragrance Lavender rose
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Helps eliminate bacteria on hands

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

Helps eliminate bacteria on hands

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, Polysorbate 20,FD&C Yellow 6, FD&C Red 40 , PEG-12 Dimethicone ,Fragrance Lavender Rose ORC1004596.

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 SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-015-012025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-022025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-032025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-042025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-052025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-062025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-072025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-082025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-092025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-102025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-112025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-122025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-132025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-142025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-152025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-162025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-172025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-182025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-192025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-202025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-212025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-222025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-232025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-242025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-252025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-262025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-272025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-282025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-292025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-302025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-312025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-322025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-332025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60
80948-015-342025-01-30C16284748780-12cef2736-61d6-d83d-e063-dadaa90ab31f87dfce36-498c-4def-bae7-8f28d8739e60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-015-01PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-01PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-02PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-02PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-03PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-03PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-04PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-04PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-05PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-05PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 PACKAGELIQUID1783
80948-015-06PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-06PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-07PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-07PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-08PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-08PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-09PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-09PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-10PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-10PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-11PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-11PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-12PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-12PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-13PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-13PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-14PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-14PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-15PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-15PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-16PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-16PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-17PUROMA Antibacterial Hand Wash with Fragrance Lavender rose326 mL in 1 BOTTLELIQUID3263
80948-015-17PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-18PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-18PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-19PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-19PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-20PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-20PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-21PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-21PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-22PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-22PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123
80948-015-23PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-23PUROMA Antibacterial Hand Wash with Fragrance Lavender rose24 in 1 PACKAGELIQUID243
80948-015-24PUROMA Antibacterial Hand Wash with Fragrance Lavender rose947 mL in 1 BOTTLELIQUID9473
80948-015-24PUROMA Antibacterial Hand Wash with Fragrance Lavender rose2 in 1 PACKAGELIQUID23
80948-015-25PUROMA Antibacterial Hand Wash with Fragrance Lavender rose947 mL in 1 BOTTLELIQUID9473
80948-015-25PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-26PUROMA Antibacterial Hand Wash with Fragrance Lavender rose5000 mL in 1 CANLIQUID50003
80948-015-27PUROMA Antibacterial Hand Wash with Fragrance Lavender rose50000 mL in 1 CANLIQUID500003
80948-015-28PUROMA Antibacterial Hand Wash with Fragrance Lavender rose200000 mL in 1 DRUMLIQUID2000003
80948-015-29PUROMA Antibacterial Hand Wash with Fragrance Lavender rose237 mL in 1 BOTTLELIQUID2373
80948-015-30PUROMA Antibacterial Hand Wash with Fragrance Lavender rose474 mL in 1 BOTTLELIQUID4743
80948-015-31PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-31PUROMA Antibacterial Hand Wash with Fragrance Lavender rose4 in 1 PACKAGELIQUID43
80948-015-32PUROMA Antibacterial Hand Wash with Fragrance Lavender rose6 in 1 PACKAGELIQUID63
80948-015-32PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-33PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-33PUROMA Antibacterial Hand Wash with Fragrance Lavender rose8 in 1 PACKAGELIQUID83
80948-015-34PUROMA Antibacterial Hand Wash with Fragrance Lavender rose178 mL in 1 BOTTLELIQUID1783
80948-015-34PUROMA Antibacterial Hand Wash with Fragrance Lavender rose12 in 1 PACKAGELIQUID123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-015PUROMA ANTIBACTERIAL HAND WASH WITH FRAGRANCE LAVENDER ROSE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 63 package rows20231215_87dfce36-498c-4def-bae7-8f28d8739e60.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-01580948-015-01, 80948-015-02, 80948-015-03, 80948-015-04, 80948-015-05, 80948-015-06, 80948-015-07, 80948-015-08, 80948-015-09, 80948-015-10, 80948-015-11, 80948-015-12, 80948-015-13, 80948-015-14, 80948-015-15, 80948-015-16, 80948-015-17, 80948-015-18, 80948-015-19, 80948-015-20, 80948-015-21, 80948-015-22, 80948-015-23, 80948-015-24, 80948-015-25, 80948-015-26, 80948-015-27, 80948-015-28, 80948-015-29, 80948-015-30, 80948-015-31, 80948-015-32, 80948-015-33, 80948-015-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYSORBATE 207T1F30V5YHIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
FRAGRANCE LAVENDER ROSE ORC10045961XW43TV4PIIACT
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

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
0c781cb2-d8ce-562d-e063-6294a90af95d87dfce36-498c-4def-bae7-8f28d8739e602023-12-14WarningsExact identifier
spl id: 0c781cb2-d8ce-562d-e063-6294a90af95d
spl set id: 87dfce36-498c-4def-bae7-8f28d8739e60

Reported adverse events (FAERS/openFDA)#

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