PUREASE HYGIENIC FACIAL SKIN CLEANSING CLOTHS- laurylpyridinium chloride liquid 
Eunhye Tissue

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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80503-201

Active ingredient

Laurylpyridinium Chloride 0.07%

Purpose

Antimicrobial

Use

decreases bacteria on skin

Warnings

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and over

Children under 2 years

Ask a doctor before use

Inactive ingredients

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

Package Label

55g NDC: 80503-201-01 Label 1

55g NDC: 80503-201-01 Label 2

55g NDC: 80503-201-01 Label 3

PUREASE HYGIENIC FACIAL SKIN CLEANSING CLOTHS 
laurylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80503-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL) (LAURYLPYRIDINIUM - UNII:34G1X4D9HS) LAURYLPYRIDINIUM0.07 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL LAURATE (UNII: Y98611C087)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CHLORIDE ION (UNII: Q32ZN48698)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
LEVULINIC ACID (UNII: RYX5QG61EI)  
WATER (UNII: 059QF0KO0R)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80503-201-0155 g in 1 POUCH; Type 0: Not a Combination Product09/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/08/2020
Labeler - Eunhye Tissue (695589871)
Registrant - Eunhye Tissue (695589871)
Establishment
NameAddressID/FEIBusiness Operations
Eunhye Tissue695589871manufacture(80503-201)

Revised: 9/2020
Document Id: aec34068-a24b-7549-e053-2995a90ac6fc
Set id: aec34068-a24a-7549-e053-2995a90ac6fc
Version: 1
Effective Time: 20200907
 
Eunhye Tissue