Label: ALCOHOL WIPE- alcohol cloth

  • NDC Code(s): 79618-001-02
  • Packager: YAHON ENTERPRISE 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 December 21, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 75% (alc/vol)

  • Purpose

    Antiseptic

  • Use

    Sanitizing wipes to help reduce bacteria on the skin or surface

  • Warnings

    Do not apply internally.

    Flammable, keep away from heat, spark, electrical fire or flame.

  • WHEN USING

    Avoid contact with eyes. If in eyes, remove contact lenses (if any), rinse slowly with water or get medical help.

  • STOP USE

    Irritation and redness develop or condition persists for more than 72 hours

    Ask a dctor if you have you have deep or puncture wounds, animal bites serious burns

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Discard after single use and do not flush

  • Other information

  • Inactive ingredients

    Water, Benzalkonium Chloride, Polyaminopropyl Biguanide, Citric Acid

  • Package Label - Principal Display Panel

    Complete LabelPrincipal Display PanelDrug Facts10 wipes NDC:79618-001-02

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79618-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79618-001-0210 in 1 PACKET; Type 0: Not a Combination Product07/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2020
    Labeler - YAHON ENTERPRISE CO.,LTD (555347945)
    Establishment
    NameAddressID/FEIBusiness Operations
    YAHON ENTERPRISE CO.,LTD555347945manufacture(79618-001)
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