Label: PUREASE HYGIENIC FACIAL SKIN CLEANSING CLOTHS- laurylpyridinium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 7, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    • Apply to hands
    • Allow to dry without wiping

    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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!