Label: ANTISEPTIC SANITIZING 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 July 8, 2021

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  • Active Ingredient

    lsopropyl Alcohol75%.

    Purpose

    Antiseptic

  • USE

    To decrease bacteria.
    Recommended for repeated use.

  • Warning

    Do not use
    ln the eyes
    For external use only.
    These wipes do not replace wipes used for
    medical procedures.These wipes are
    meant for general cleaning.
    Stop use and ask doctor if:
    lrritation and redness develops
    Condition persists for more than 72 hours

    Keep out of reach of children. If
    swallowed, get medical help or contact
    a poison control center right away.

  • Directions

    ■Wet hands thoroughly with product and
    allow to dry without wiping.

  • Inactive ingredients

    Purified water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SANITIZING WIPES 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75714-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75714-003-0150 in 1 BAG09/01/2020
    12.43 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:75714-003-0280 in 1 BAG09/01/2020
    22.43 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:75714-003-03100 in 1 BAG09/01/2020
    32.43 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:75714-003-04120 in 1 BAG09/01/2020
    42.43 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:75714-003-0590 in 1 BAG09/01/2020
    52.43 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:75714-003-0650 in 1 BAG09/01/2020
    62.7 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:75714-003-0780 in 1 BAG09/01/2020
    72.7 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:75714-003-0880 in 1 CANISTER09/01/2020
    82.7 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:75714-003-0935 in 1 CANISTER09/01/2020
    92.43 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:75714-003-1090 in 1 CANISTER09/01/2020
    102.43 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - HANGZHOU CLEAN NONWOVEN CO.,LTD (560795987)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU CLEAN NONWOVEN CO.,LTD560795987manufacture(75714-003)
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