PURILAB

Manufacturer
Seoul Food Research & Development Co., Ltd.
Effective date
2020-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:21

Label at a glance#

ProductPURILAB
Active ingredientCITRIC ACID MONOHYDRATE
Label structure9 sections

Indications and uses

■ Disinfectant to help reduce bacteria on the skin and surfaces ■ Recommended for repeated use

Dosage and administration

■ Place enough product on hands to cover all surfaces. Rub hands together until dry. ■ Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Citiric acid 0.026% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Ascorbic acid, Citrus extract, Citric extractives, DL-Malic acid, Ethanol, Lactic acid, Saccharum officinarum extract, Water

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

WARNINGS

WARNINGS SECTION

For external use only

When using this product ■ Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.

Stop use and ask a doctor if skin irritation or rash develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

■ Disinfectant to help reduce bacteria on the skin and surfaces
■ Recommended for repeated use

Directions

DOSAGE & ADMINISTRATION SECTION

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

OTHER SAFETY INFORMATION

■ Store between 15-30℃(59-86℉)
■ Avoid freezing and excessive heat above 40℃(104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80642-060-012024-01-30C16284748780-11030e365-3c52-111a-e063-dadaa90a10e22e893bf2-40fc-46f0-b310-880f176a747e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80642-060-01PURILAB500 mL in 1 BOTTLE, SPRAYSPRAY5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80642-060PURILAB (CITIRIC ACID) SPRAY [SEOUL FOOD RESEARCH & DEVELOPMENT CO., LTD.]1Legacy NDC, 1 package rows20201024_2e893bf2-40fc-46f0-b310-880f176a747e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80642-06080642-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
be51affd-e77f-47a6-be96-af503e236c612e893bf2-40fc-46f0-b310-880f176a747e2020-10-23WarningsExact identifier
spl id: be51affd-e77f-47a6-be96-af503e236c61
spl set id: 2e893bf2-40fc-46f0-b310-880f176a747e

Reported adverse events (FAERS/openFDA)#

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