Label: CORALITE ANTIBACTERIAL MOIST- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 4, 2023

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

View All Sections
  • Drug Facts


    Active Ingredient                                                                                      Purpose

    Benzalkonium Chloride 0.115%............................................................ Antibacterial

  • PURPOSE

    Uses

    • Decreases bacteria on skin and surfaces
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with the eyes, if contact occurs rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if

    • Irritation or rash develops and persists for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • Peel back seal using tab. Do not pull seal all the way off. Pull sheet from center and remove as needed. Reseal pouch by pressing seal back down to retain moisture after each use.
    • Apply thoroughly to hands and face as desired and allow to dry without wiping.
    • Dispose of wipe in the proper container. Do not flush down the toilet.
  • INACTIVE INGREDIENT

    Inactive ingredients

    2-Bromo-2-Nitropropane-1,3-Diol,3-Iodo-2-propynyl Butyl Carbamate, Aloe Gel Powder 100:1, Aqua, Chamomilla Recutita Flower Extract (Propylene Glycol, Aqua), Citric Acid, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Terasodium EDTA

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNITED EXCHANGE CORP.

    17211 Valley View Ave.

    Cerritos, CA 90703

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE ANTIBACTERIAL MOIST 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-831
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g
    Inactive Ingredients
    Ingredient NameStrength
    BRONOPOL (UNII: 6PU1E16C9W)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-831-3030 in 1 POUCH; Type 0: Not a Combination Product09/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/26/2013
    Labeler - United Exchange Corp. (840130579)
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!