Label: ALOESEPT HS- ethanol liquid

  • NDC Code(s): 63647-001-18, 63647-001-34
  • Packager: Walter G. Legge Company, Inc.
  • 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 April 10, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
    • Recommended for repeated use.
  • WARNINGS

    ​Warnings

    • For external use only.

    Keep out of eyes, ears, or mouth.

    • Discontinue use if irritation occurs.

    • Keep out of reach of children.

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

  • DOSAGE & ADMINISTRATION

    Directions

    • If hands are visibly soiled, wash with soap and water and dry hands.
    • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.
  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

  • SPL UNCLASSIFIED SECTION

    Sold By: Walter G. Legge Company Inc.

    444 Central Avenue, Peekskill, N.Y. 10566

    1-800-345-3443

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    ALOESEPT HS

    WATERLESS HAND SANITIZER

    Compliant with CDC Hand Hygiene Guidelines.

    Kills more than 99.99% of germs in 15 seconds.

    Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes or fragrances.

    CONTAINS MOISTURIZING AGENTS

    1000 ml

    63647-001 label

  • INGREDIENTS AND APPEARANCE
    ALOESEPT HS 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63647-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63647-001-18532 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2021
    2NDC:63647-001-341000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/12/2021
    Labeler - Walter G. Legge Company, Inc. (001382274)