Label: SANITIZING WIPES- alcohol 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 August 25, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.1%

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin.

    For use when soap and water are not available.

  • WARNINGS

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

  • DO NOT USE

    in children less than 2 months of age
    on open skin wounds

  • 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 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

    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

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

  • DOSAGE & ADMINISTRATION

    Open packet, remove and unfold pre-moistened tissue. Wipe hands or affected area thoroughly, then discard properly after use. Reseal back after use to keep wipes fresh.

  • STORAGE AND HANDLING

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Phenoxy Ethanol, Polyhexamethylene Biguanide Hydrochloride, Purified Water, Propylene Glycol, Ethyl Alcohol, Vitamin E, Lemon Terpenes, Aloe Vera Extract.

  • PRINCIPAL DISPLAY PANEL

    10 wipes NDC: 80144-001-01

    10 wipes label

    35 wipes NDC: 80144-001-02

    35 wipes label

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80144-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 95.61 mg  in 100 mg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mg  in 100 mg
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.05 mg  in 100 mg
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496) 0.02 mg  in 100 mg
    ALCOHOL (UNII: 3K9958V90M) 4 mg  in 100 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.05 mg  in 100 mg
    LEMON TERPENES (UNII: 5DHA4TVW63) 0.02 mg  in 100 mg
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.1 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80144-001-0110 mg in 1 POUCH; Type 0: Not a Combination Product08/19/2020
    2NDC:80144-001-0235 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2020
    Labeler - Condor Co., Ltd. (560075779)
    Registrant - Condor Co., Ltd. (560075779)
    Establishment
    NameAddressID/FEIBusiness Operations
    Condor Co., Ltd.560075779manufacture(80144-001)
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