Label: HARBA HAND SANITIZER- alcohol liquid

  • 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 January 26, 2021

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 65% 

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to decrease bacteria on skin

    • Recommended for repeated use

  • WARNINGS

    For external use only. Flammable. 

    Keep away from fire or flame.

    When using this product avoid contact with face, eyes and broken skin. If eye contact occurs,

    flush thoroughly with water and seek medical advice.

    Stop use and ask a doctor if irritation and redness develops.

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Wet hands thoroughly with product and rub into skin until dry.

    • Children under 6 years of age should be supervised by an adult when using this product  

  • Inactive Ingredients:

    Water (Aqua), Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Piperita (Peppermint) Oil, Panthenol, Tocopheryl Acetate, Fragrance(Parfum). 

  • SPL UNCLASSIFIED SECTION

    With Pro-Vitamins

    DISINFECTANTS & PROTECTS AGAINST COMMON GERMS

    JF LABS INC. Chicago,IL 60629

    (800)262-2326 Watford WD247GN, UK

    www.afamconcept.com

    ISO and cGMP compliant

    MADE IN USA

  • Packaging

    IMAGE1

    IMG2

  • INGREDIENTS AND APPEARANCE
    HARBA HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-300-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    2NDC:49681-300-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    3NDC:49681-300-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    4NDC:49681-300-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    5NDC:49681-300-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    6NDC:49681-300-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/26/2020
    Labeler - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140manufacture(49681-300)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!