Label: ALCOHOL CLEANSING WIPE- alcohol cloth

  • NDC Code(s): 83165-001-00
  • Packager: Hubei Fanjian Medical Product Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • DRUG FACTS

  • Active ingredients

    Ethyl alcohol 62% v/v

    Purpose

    `Antiseptic

  • Use

    For preparation of the skin before injection.

  • Warnings:

    For external use only.

    Flammable, keep away from fire or flame

    Do not use:

    elerctrocauf-bi in the eyes

    Stop use

    if imitation and redness develop. If condition persists for more than 72 hours, consult your doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Wipe injection site vigorously and discard.

  • Other information:

    Store at room temperature15°-30° C (59°-86° F)

  • Inactive ingredients

    Purified water.

  • Package Labeling:

    Label3Box03

  • INGREDIENTS AND APPEARANCE
    ALCOHOL CLEANSING WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83165-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83165-001-000.62 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/14/2023
    Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Fanjian Medical Product Co.,Ltd846385590manufacture(83165-001)
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