FDA.reportPublic FDA data

PUROMA Hand Sanitizer Wipe Alcohol Free

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:25

Label at a glance#

ProductPUROMA Hand Sanitizer Wipe Alcohol Free
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

Pull out one sheet from the pack. Clean hands or affected area. Discard wipes in trash receptacle after use. Do not flush. Close lid after each used to keep wipes fresh.

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

Pull out one sheet from the pack. Clean hands or affected area.

Discard wipes in trash receptacle after use.

Do not flush.

Close lid after each used to keep wipes fresh.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, Peg-7 Glyceril Cocoate, Glyceril Oleate, Glycerin, Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol.

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
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-011-012025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-022025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-032025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-042025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-052025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-062025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-072025-01-30C16284748780-12cef2736-6cb1-d83d-e063-dadaa90ab31faf8f7588-93f8-491d-8c2b-6ef31c199027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-011-01PUROMA Hand Sanitizer Wipe Alcohol Free66 mL in 1 PACKAGECLOTH662
80948-011-01PUROMA Hand Sanitizer Wipe Alcohol Free10 in 1 PACKAGECLOTH102
80948-011-02PUROMA Hand Sanitizer Wipe Alcohol Free132 mL in 1 PACKAGECLOTH1322
80948-011-02PUROMA Hand Sanitizer Wipe Alcohol Free20 in 1 PACKAGECLOTH202
80948-011-03PUROMA Hand Sanitizer Wipe Alcohol Free40 in 1 PACKAGECLOTH402
80948-011-03PUROMA Hand Sanitizer Wipe Alcohol Free264 mL in 1 PACKAGECLOTH2642
80948-011-04PUROMA Hand Sanitizer Wipe Alcohol Free80 in 1 PACKAGECLOTH802
80948-011-04PUROMA Hand Sanitizer Wipe Alcohol Free528 mL in 1 PACKAGECLOTH5282
80948-011-05PUROMA Hand Sanitizer Wipe Alcohol Free120 in 1 PACKAGECLOTH1202
80948-011-05PUROMA Hand Sanitizer Wipe Alcohol Free792 mL in 1 PACKAGECLOTH7922
80948-011-06PUROMA Hand Sanitizer Wipe Alcohol Free350 mL in 1 CANISTERCLOTH3502
80948-011-06PUROMA Hand Sanitizer Wipe Alcohol Free50 in 1 CANISTERCLOTH502
80948-011-07PUROMA Hand Sanitizer Wipe Alcohol Free700 mL in 1 CANISTERCLOTH7002
80948-011-07PUROMA Hand Sanitizer Wipe Alcohol Free100 in 1 CANISTERCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-011PUROMA HAND SANITIZER WIPE ALCOHOL FREE (BENZALKONIUM CHLORIDE) CLOTH [ZENITH MICRO CONTROL]2Legacy NDC, 14 package rows20231215_af8f7588-93f8-491d-8c2b-6ef31c199027.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-01180948-011-01, 80948-011-02, 80948-011-03, 80948-011-04, 80948-011-05, 80948-011-06, 80948-011-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
GLYCERINPDC6A3C0OXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYSORBATE 207T1F30V5YHIACT
ALOE VERA LEAFZY81Z83H0XIACT
BETAINE3SCV180C9WIACT
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
0c783860-aac0-1b67-e063-6394a90ae93baf8f7588-93f8-491d-8c2b-6ef31c1990272023-12-14WarningsExact identifier
spl id: 0c783860-aac0-1b67-e063-6394a90ae93b
spl set id: af8f7588-93f8-491d-8c2b-6ef31c199027

Reported adverse events (FAERS/openFDA)#

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