Label: ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 75109-521-04, 75109-521-05, 75109-521-06
  • Packager: Kangna (Zhejiang) Medical Supplies Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 12, 2023

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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 or flame.
    When using this product keep out of eyes, ears, and mouth. In case of eye contact,flush thoroughly with water.
    · Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    -Gently pull back resealable label, remove and use wipes as required.
    -Reseal back after use to avoid evaporation of alcohoil.

  • Inactive ingredients

    Water

  • PRINCIPAL DISPLAY PANEL

    1234

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-521
    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:75109-521-0410 in 1 BAG03/09/2021
    149 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:75109-521-0550 in 1 BAG03/09/2021
    2236 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:75109-521-0675 in 1 BAG03/09/2021
    3408 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/09/2021
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-521)
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