Label: ALCOHOL WIPE- alcohol cloth

  • NDC Code(s): 79618-001-08
  • 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)

    Alcohol 75%. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    To decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WHEN USING

    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 redness develop or last more than 72 hours

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

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

  • 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

    Rub wire thoroughly over all surfaces of both hands and allow to dry.

    Supervise children under 6 years old.

    Not recommended for infants

    Discard wipe in trash; do not flush

  • Inactive ingredients

    Benzalkonium Chloride, Citric Acid, Polyaminopropyl Biguanide Water

  • Package Label - Principal Display Panel

    Front and Back Labels50 wipes NDC: 79618-001-08

  • 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
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79618-001-0850 in 1 PACKET; Type 0: Not a Combination Product10/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/31/2020
    Labeler - YAHON ENTERPRISE CO.,LTD (555347945)
    Establishment
    NameAddressID/FEIBusiness Operations
    YAHON ENTERPRISE CO.,LTD555347945manufacture(79618-001)
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