Label: 15PCS ANTIBACTRIAL WIPES- alcohol swab

  • NDC Code(s): 71734-106-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES 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 December 10, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethly Alcohol ................  75%

  • Purpose

    Antiseptic Cleanser

  • Uses:

    For hand sanitizing to decrease bacteria on the skin; Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only. 

    • When using this product avoid contact with the eyes. In case of contact,flush eyes thoroughly with water ;
    • Stop use and ask a doctor if irritation and redness develop and persist.

    Keep out of reach of children.

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

  • Directions

    Take wipe from pouch and rub thoroughly over all surfaces of both hands.

    Rub hands together briskly to dry.

    Disopose of wipe.

  • Inactive Ingredients:

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    15PCS ANTIBACTRIAL WIPES 
    alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-106-0115 in 1 BAG12/10/2021
    14.3 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 finalpart333A12/10/2021
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-106)