Label: 50CT ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 75109-520-01
  • Packager: Kangna (Zhejiang) Medical Supplies 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 January 14, 2022

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  • Active Ingredient

    Ethanol 75%

    Purpose

    Antiseptic

  • USE

    Uses■for hand sanitizing to decrease bacteria on the skin■apply
    topically to the skin to help prevent cross contamination■not recommended
    for repeated use■dries in seconds

  • Warning

    For external use only.

    flammable, keep away from fire and flame

    when using this product do not use in or contact the eyes.

    stop use and ask a doctor if too much skin irritation or sensitivity develops or increases

    ■keep out of reach of children. If swallowed, contact medical help or call Poison Control immediately.

  • Directions

    ●Open lid, gently pull back resealable label, remove and use
    wipe as required.
    ●Reseal back after use to avoid evaporation of alcohol.

  • Inactive ingredients

    Water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    50CT ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75109-520-0150 in 1 BAG10/30/2020
    1151.87 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/30/2020
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-520)