Label: CPAP WIPES cloth

  • NDC Code(s): 43116-031-01
  • Packager: Shenzhen Shierjie Biological Engineering Co., LTD
  • 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 August 3, 2023

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

View All Sections
  • Active Ingredient


    Phenoxyethanol 0.3%

  • Purpose


    Cleaning

  • Uses

    CPAP WIPES to help to clean and reduce bacteria that potentially can cause disease.
    For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    On children less than 2 months of age
    On open skin wounds

  • When using this product

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Stop use and ask a doctor if


    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children


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

  • Directions


    Wipe your CPAP Mask after each use and discard the wipe after cleaning. Let CPAP mask air dry. Keep cover closed in between uses to prevent drying. If irritation occurs discontinue use and seek medical advice. Store in a cool dry place.

  • Other information

    -N/A

  • Inactive ingredients

    DMDMH, Water (Aqua)

  • PRINCIPAL DISPLAY PANEL

    43116-031-01

  • INGREDIENTS AND APPEARANCE
    CPAP WIPES 
    cpap wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-031
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.3 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDANTOIN (UNII: I6208298TA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43116-031-0170 in 1 PACKET; Type 0: Not a Combination Product08/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/04/2023
    Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)
    Registrant - Shenzhen Shierjie Biotech Co .,LTD (547610261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Shierjie Biological Engineering Co., LTD547610261manufacture(43116-031)
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!