Label: ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 75109-503-01, 75109-503-02, 75109-503-03, 75109-503-04, view more
    75109-503-05, 75109-503-06, 75109-503-07, 75109-503-08, 75109-503-09, 75109-503-10, 75109-503-11, 75109-503-12, 75109-503-13, 75109-503-14, 75109-503-15, 75109-503-16, 75109-503-17, 75109-503-18, 75109-503-19, 75109-503-20, 75109-503-21, 75109-503-22, 75109-503-23, 75109-503-24, 75109-503-25, 75109-503-26
  • 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 14, 2022

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  • Active Ingredient

    Ethyl Alcohol 75%

    Purpose

    Antiseptic

  • USE

    ●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

    ●Flammable, Keep away from fire or flame. For
    external use only.
    ●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, get medical
    help or contact a Poison Control Center immediately.

  • Directions

    ●Remove lid and discard seal from container.
    ●Pull wipe from center of roll and thread through opening in lid.
    Do not push finger through opening.
    ●Replace lid, pull wipe up, and then out at a 45° angle. The next
    wipe dispenses automatically.
    ●Close lid to retain moisture.

  • Inactive ingredients

    Water

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-503
    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:75109-503-01100 in 1 BOX06/21/2020
    12 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:75109-503-0250 in 1 BOX06/21/2020
    22.8 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:75109-503-035 in 1 PACKAGE06/21/2020
    318.9 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:75109-503-0410 in 1 PACKAGE06/21/2020
    437.8 mL in 1 POUCH; Type 0: Not a Combination Product
    5NDC:75109-503-0525 in 1 PACKAGE06/21/2020
    594.5 mL in 1 POUCH; Type 0: Not a Combination Product
    6NDC:75109-503-0650 in 1 PACKAGE06/21/2020
    6189 mL in 1 POUCH; Type 0: Not a Combination Product
    7NDC:75109-503-0750 in 1 CASE06/21/2020
    724 in 1 PACKAGE
    7189 mL in 1 POUCH; Type 0: Not a Combination Product
    8NDC:75109-503-0880 in 1 PACKAGE06/21/2020
    8302.4 mL in 1 POUCH; Type 0: Not a Combination Product
    9NDC:75109-503-09100 in 1 PACKAGE06/21/2020
    9378 mL in 1 POUCH; Type 0: Not a Combination Product
    10NDC:75109-503-1040 in 1 CANISTER06/21/2020
    10181.44 mL in 1 POUCH; Type 0: Not a Combination Product
    11NDC:75109-503-11100 in 1 CANISTER06/21/2020
    11408.24 mL in 1 POUCH; Type 0: Not a Combination Product
    12NDC:75109-503-1270 in 1 CANISTER06/21/2020
    12126.224 mL in 1 POUCH; Type 0: Not a Combination Product
    13NDC:75109-503-1370 in 1 CANISTER06/21/2020
    13141.12 mL in 1 POUCH; Type 0: Not a Combination Product
    14NDC:75109-503-14100 in 1 CANISTER06/21/2020
    14272.16 mL in 1 POUCH; Type 0: Not a Combination Product
    15NDC:75109-503-15150 in 1 CANISTER06/21/2020
    15235.2 mL in 1 POUCH; Type 0: Not a Combination Product
    16NDC:75109-503-16160 in 1 CANISTER06/21/2020
    16333.8496 mL in 1 POUCH; Type 0: Not a Combination Product
    17NDC:75109-503-17100 in 1 CANISTER06/21/2020
    17186.2 mL in 1 POUCH; Type 0: Not a Combination Product
    18NDC:75109-503-18800 in 1 PACKAGE06/21/2020
    181515.136 mL in 1 POUCH; Type 0: Not a Combination Product
    19NDC:75109-503-191200 in 1 PACKAGE06/21/2020
    192272.704 mL in 1 POUCH; Type 0: Not a Combination Product
    20NDC:75109-503-2010 in 1 PACKAGE06/21/2020
    2037.8 mL in 1 POUCH; Type 0: Not a Combination Product
    21NDC:75109-503-2125 in 1 PACKAGE06/21/2020
    2194.5 mL in 1 POUCH; Type 0: Not a Combination Product
    22NDC:75109-503-2250 in 1 PACKAGE06/21/2020
    22189 mL in 1 POUCH; Type 0: Not a Combination Product
    23NDC:75109-503-2370 in 1 CANISTER06/21/2020
    23236.572 mL in 1 POUCH; Type 0: Not a Combination Product
    24NDC:75109-503-24100 in 1 CANISTER06/21/2020
    24186.2 mL in 1 POUCH; Type 0: Not a Combination Product
    25NDC:75109-503-25800 in 1 PACKAGE06/21/2020
    251515.136 mL in 1 POUCH; Type 0: Not a Combination Product
    26NDC:75109-503-261200 in 1 PACKAGE06/21/2020
    262272.704 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 finalpart333A06/20/2020
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-503)
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