Label: 99.99% DISINFECTION WIPES cloth

  • 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 September 4, 2020

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

  • Active Ingredient(s)

    Benzalkonium chloride (0.13%)
    Potassium sorbate(0.6%)
    Chlorphenesin(0.37%)

  • Purpose

    /

  • Use

    Instruction for use

  • Warnings

    When using this product
    Caution:Please put it in a cootapd dry place, avoid direct sunlight, do not let children touch it

  • Do not use

    /

  • WHEN USING

    Caution:Please put it in a cootapd dry place, avoid direct sunlight, do not let children touch it

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    /

  • Directions

    Gently open the protective seal
    Remove the wipes from the package and use it directly on the skin
    Use the wipe to clean and avoid to use on sensitive areas, such as eyes and wounds
    Once you have finished, close the package by pressing the protactive seal
    Avoid to keep the protective seal uncovered

  • Other information

    /

  • Inactive ingredients

    Aqua(75%)

  • Package Label - Principal Display Panel

    80515-002-06 80P80515-002-05 60P80515-002-02 20P80515-002-04 50P80515-002-07 100P80515-002-03 40P80515-002-01 10P

  • INGREDIENTS AND APPEARANCE
    99.99% DISINFECTION WIPES 
    99.99% disinfection wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80515-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) (SORBIC ACID - UNII:X045WJ989B) POTASSIUM SORBATE0.6 g  in 100 
    CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN0.37 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80515-002-0220 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:80515-002-0340 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:80515-002-0450 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:80515-002-0560 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:80515-002-0680 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    6NDC:80515-002-07100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    7NDC:80515-002-0110 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - QUANZHOU V-CARE SANITARY PRODUCTS CO.,LTD (543052297)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU V-CARE SANITARY PRODUCTS CO.,LTD543052297manufacture(80515-002)