FDA.reportPublic FDA data

Purease Hygienic Facial Skin Cleansing Cloths

Manufacturer
Eunhye Tissue
Effective date
2020-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:07

Label at a glance#

ProductPurease Hygienic Facial Skin Cleansing Cloths
Active ingredientLAURYLPYRIDINIUM CHLORIDE
Label structure10 sections

Dosage and administration

Adults and children 2 years and over Apply to hands Allow to dry without wiping Children under 2 years Ask a doctor before use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Laurylpyridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

DOSAGE & ADMINISTRATION SECTION

decreases bacteria on skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

INDICATIONS & USAGE SECTION

Adults and children 2 years and over

  • Apply to hands
  • Allow to dry without wiping

Children under 2 years

Ask a doctor before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glyceryl laurate, Caprylhydroxamic Acid, Sodium coco pg-dimonium chloride phosphate, Levulinic acid, Sodium levulinate, Methylpanediol, Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55g NDC: 80503-201-01 Label 155g NDC: 80503-201-01 Label 1

55g NDC: 80503-201-01 Label 255g NDC: 80503-201-01 Label 2

55g NDC: 80503-201-01 Label 355g NDC: 80503-201-01 Label 3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80503-201-012022-01-28C16284748780-1d6a99b39-4735-a426-e053-dadaa90af4c280503-201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80503-201-01Purease Hygienic Facial Skin Cleansing Cloths55 g in 1 POUCHLIQUID551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80503-201PUREASE HYGIENIC FACIAL SKIN CLEANSING CLOTHS (LAURYLPYRIDINIUM CHLORIDE) LIQUID [EUNHYE TISSUE]1Legacy NDC, 1 package rows20200912_aec34068-a24a-7549-e053-2995a90ac6fc.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
80503-20180503-201-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL LAURATEY98611C087IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CHLORIDE IONQ32ZN48698IACT
SODIUM LEVULINATEVK44E1MQU8IACT
LAURYLPYRIDINIUM CHLORIDEKJM5A6A3YLACTIM
LEVULINIC ACIDRYX5QG61EIIACT
WATER059QF0KO0RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT

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
aec34068-a24b-7549-e053-2995a90ac6fcaec34068-a24a-7549-e053-2995a90ac6fc2020-09-07WarningsExact identifier
spl id: aec34068-a24b-7549-e053-2995a90ac6fc
spl set id: aec34068-a24a-7549-e053-2995a90ac6fc

Reported adverse events (FAERS/openFDA)#

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