Label: ISSEEY ANTIBACTERIAL ALCOHOL WET WIPES- ethyl alcohol, benzalkonium chloride 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 29, 2020

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

  • Drug Facts

  • Active Ingredient

    75% Ethyl Alcohol (12% v/v)

    Benzalkonium Chloride (0.10% v/v)

  • Purpose

    Antiseptic

  • Uses

    • Apply on skin and surface to decrease bacteria and germs that may cause disease • recommended for repeated use.

  • Directions

    • Remove top cover • pull up wipe corner from center of the roll and thread through hole in the cover • open center cap on cover to remove wipe • unfold wipe to disinfect skin and surface • let air dry your skin and surface • dispose wipe after using • when done using, close center cap carefully to prevent loss moisture • when apply on dirty surface, you must clean with another wipe before disinfecting.

  • Warnings

    For external use only: hand, arm, leg and surface.

    Flammable, keep away from fire, flame or heat.

    When using this product • keep out of eye, In case of contact with eyes, flush thoroughly with water • avoid contact with broken or sensitive skin • do not use on face • do not put on your mouth.

    Stop use ask a doctor if •irritation and redness develop • If the condition persists more than 72 hours consults with doctor.

    Keep out of reach of children • if put on mouth or swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    • Not recommended for infants use • for children under 6, must use under adult supervision • do not use as diaper wipe • rinse toys or food with clean water after disinfecting • do not use on unpainted wood • do not apply on dishes, glassware or utensils to disinfect

    Storage and disposal • store wipe in original container in a cool, or dry place • keep container tightly closed • do not reuse or refill this container • do not flush • dispose wipes after using and put container in the trash.

  • Inactive ingredients

    Purified Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Fragrance.

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS 

    CONTAINING ETHYL ALCOHOL

    BLEACH FREE

    Sanitize your hand and surface with wet alcohol wipes to decrease germs and bacteria. Our wipes formulated to be gentle on skin without dyes, parabens or harsh chemicals. so that it can be used safely on your hand and washable non-porous surfaces. You can clean and disinfect by wiping surface area until visible wet, allow to remain wet until air dry.

    GENTLE ON HAND

    BEDROOM  

    KITCHEN

    BATHROOM

    APPLIANCES

    HOME OR OFFICE

    MADE IN CHINA

    Distributed By

    ISSEEY TM

    P.O. Box 2015

    Alief, TX - 77411

    Questions?

    info.isseey@gmail.com

    www.isseey.com

  • Packaging

    IMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    ISSEEY ANTIBACTERIAL ALCOHOL WET WIPES 
    ethyl alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80568-299
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80568-299-01100 in 1 CANISTER09/23/2020
    10.13 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:80568-299-02100 in 1 CANISTER09/23/2020
    20.13 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - ISSEEY (117606552)