FDA.reportPublic FDA data

PUROMA Instant Foaming Hand Sanitizer without Fragrance

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 00:04:25

Label at a glance#

ProductPUROMA Instant Foaming Hand Sanitizer without Fragrance
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin. Recommended for repeated use.

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 75% V/V

Purpose

OTC - PURPOSE SECTION

Antimicrobial.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.
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

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,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

Other information

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098198ethanol 75 % Topical FoamPSN3
1098198ethanol 0.75 ML/ML Topical FoamSCD3
1098198ethanol 75 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-012-012025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-022025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-032025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-042025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-052025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-062025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-072025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-082025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-092025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-102025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-112025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-122025-01-30C16284748780-12cef2736-91bc-d83d-e063-dadaa90ab31fae3d334f-66d7-49e3-b584-bebf1eae6ab4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-012-01PUROMA Instant Foaming Hand Sanitizer without Fragrance60 mL in 1 BOTTLELIQUID603
80948-012-02PUROMA Instant Foaming Hand Sanitizer without Fragrance80 mL in 1 BOTTLELIQUID803
80948-012-03PUROMA Instant Foaming Hand Sanitizer without Fragrance100 mL in 1 BOTTLELIQUID1003
80948-012-04PUROMA Instant Foaming Hand Sanitizer without Fragrance150 mL in 1 BOTTLELIQUID1503
80948-012-05PUROMA Instant Foaming Hand Sanitizer without Fragrance220 mL in 1 PACKAGELIQUID2203
80948-012-06PUROMA Instant Foaming Hand Sanitizer without Fragrance250 mL in 1 BOTTLELIQUID2503
80948-012-07PUROMA Instant Foaming Hand Sanitizer without Fragrance300 mL in 1 BOTTLELIQUID3003
80948-012-08PUROMA Instant Foaming Hand Sanitizer without Fragrance350 mL in 1 BOTTLELIQUID3503
80948-012-09PUROMA Instant Foaming Hand Sanitizer without Fragrance5000 mL in 1 CANLIQUID50003
80948-012-10PUROMA Instant Foaming Hand Sanitizer without Fragrance50000 mL in 1 CANLIQUID500003
80948-012-11PUROMA Instant Foaming Hand Sanitizer without Fragrance200000 mL in 1 CANLIQUID2000003
80948-012-12PUROMA Instant Foaming Hand Sanitizer without Fragrance70 mL in 1 BOTTLELIQUID703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-012PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 12 package rows20231215_ae3d334f-66d7-49e3-b584-bebf1eae6ab4.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
80948-01280948-012-01, 80948-012-02, 80948-012-03, 80948-012-04, 80948-012-05, 80948-012-06, 80948-012-07, 80948-012-08, 80948-012-09, 80948-012-10, 80948-012-11, 80948-012-12

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
CAPRYLYL GLYCOL00YIU5438UIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERYL OLEATE4PC054V79PIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
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
0c781d97-bc97-2ab9-e063-6394a90a9aa8ae3d334f-66d7-49e3-b584-bebf1eae6ab42023-12-14WarningsExact identifier
spl id: 0c781d97-bc97-2ab9-e063-6394a90a9aa8
spl set id: ae3d334f-66d7-49e3-b584-bebf1eae6ab4

Reported adverse events (FAERS/openFDA)#

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