Label: APLICARE ANTISEPTIC HAND RINSE- ethanol gel

  • NDC Code(s): 52380-0540-1
  • Packager: Aplicare Products, LLC
  • 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 15, 2022

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  • Active ingredient

    Alcohol denat. (anhydrous) 62%

  • Purpose

    Antiseptic

  • Use

    instant hand antiseptic

  • Warnings

    For external use only. Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Flammable. Keep away from fire or flame.

    Stop use and ask a doctor if

    significant irritation or sensitization ocurs

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    • apply to clean, dry hands
    • wet hands thoroughly with product and allow to dry
  • Other information

    • not made with natural rubber latex
    • recommended for repeated use
    • reduces bacteria that can potentially cause disease
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, diisopropanolamine, FD&C blue no. 1, FD&C yellow no. 5, fragrance, PPG-20 methyl, glucose ether, water

  • Questions or comments?

    1 800 633-5463

  • Manufacturing Information

    Manufactured by:

    Aplicare Products, LLC

    550 Research Parkway, Meriden, CT 06450 USA

    Made in USA

    REF: APLL1540

    RJ19APL

  • Package Label

    Label Front

    Label Back

  • INGREDIENTS AND APPEARANCE
    APLICARE ANTISEPTIC HAND RINSE 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0540-11.5 mL in 1 PACKET; Type 0: Not a Combination Product02/14/201807/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/200607/31/2025
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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