Label: DISINFECTING WIPES- isopropyl 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 December 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Disinfecting Wipes

  • Active Ingredient(s)

    Isopropyl alcohol 1mL/pcs. Purpose: Antiseptic

  • Purpose

    Antiseptic, Disinfecting Wipes

  • Use

    Disinfecting Wipes to help reduce bacteria that potentially can cause disease. 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.

  • Directions

    • Wipe the surface of the skin and let it dry naturally.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Quaternary ammonium compounds,C12-18-alkyl[(ethylphenyl) methyl] dimethyl,chlorides
    n-Alkyl Dimethyl Benzyl Ammonium Chloride
    Water
    Phenoxyethanol
    Propylene Glycol
    Disodium EDTA
    Polysorbate 20
    Fragrance

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80707-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    3-CHLORO-2-HYDROXYPROPYLCOCOALKYLDIMETHYLAMMONIUM CHLORIDE (UNII: 0V8LAK7MX8)  
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80707-301-01160 in 1 CANISTER; Type 0: Not a Combination Product12/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/18/2020
    Labeler - Hangzhou Muzi Commodity Co., Ltd (554551057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Muzi Commodity Co., Ltd554551057manufacture(80707-301)
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