Label: CPAP MASK CLEANING WIPES- benzethonium chloride and benzalkonium chloride cloth

  • NDC Code(s): 71734-212-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
  • 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 June 7, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Benzethonium Chloride 0.03%

    Benzalkonium Chloride 0.02%

  • Purpose

    Antiseptic and antifungal

  • Uses:

    Removes oil ,dirt and grime from your CPAP mask,prepping your mask for daily cleaning with activated oxygen.

  • WARNINGS

    For external use only.

    • for external use only.
    • do not use in eyes. If this occurs, rinse thoroughly with water.
    • Stop use and ask a doctor if irritation o redness develops and persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    Removes oil ,dirt and grime from your CPAP mask,prepping your mask for daily cleaning with activated oxygen.

  • Inactive Ingredients:

    Purified water, Sodium Dehydroacetate, Organic Silicon Defoamer, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CPAP MASK CLEANING WIPES 
    benzethonium chloride and benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.03 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-212-011.2 g in 1 PACKAGE; Type 0: Not a Combination Product06/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/07/2019
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-212)
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!