Label: 75% ALCOHOL HAND SANITIZING WIPES- 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 October 15, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ethyl alcohol 75% v/v.

  • PURPOSE

    Antiseptic

  • DOSAGE & ADMINISTRATION

    For external use only.KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Water

  • INDICATIONS & USAGE

    Antibacterial (skin) cleanser. Kills harmful bacteria /germs. For personal hand hygiene to help prevent the spread of bacteria.

    Adults and children over 2 years:
    For occasional and personal domestic use.
    Supervise children when they use this product.
    Wipe hands thoroughly.
    Let the skin dry and discard.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    For external use only.
    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    80wipe NDC:80199-009-01 80patch

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80199-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.25 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80199-009-0180 in 1 CONTAINER10/14/2020
    11.71 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/14/2020
    Labeler - E-Fresh Food Ltd. (203413216)