Label: SEPTOSAN 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 October 6, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethanol 60%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    For use as a healthcare personnel hand antiseptic to reduce risk of disease transfer.

  • Warnings

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. FOR EXTERNAL USE ONLY.

    Keep away from eyes. In case of eye contact, flush thoroughly with water and seek medical advice. If swallowed, drink large amounts of water and seek medical attention. Avoid contact with face and broken skin. If contact occurs, flush with water.

    If irritation develops, discontinue use.

    If condition persists, consult a physician.

    Keep out of the reach of children.

  • STORAGE AND HANDLING

    Note: Do not store above 100°F. Non-staining. May discolor some fabrics.

  • Directions

    Dispense an adequate amount in your palm to cover all surfaces of hands completely. Rub hands together until dry. Does not require rinsing.

  • Other Ingredients

    Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, Retinyl Palmitate.

  • Questions or Comments?

    800-872-8305

  • SPL UNCLASSIFIED SECTION

    Distributed by SEPTODONT
    416 S. Taylor Ave | Louisville, CO 80027
    800-872-8305 | www.septodontusa.com
    Made in the USA

  • PRINCIPAL DISPLAY PANEL - 1.89L Bottle Label

    septodont

    SeptoSan

    Hand Sanitizer
    Enriched with Vitamins A & E

    Clinically Proven to Kill 99.99%
    of Germs in Seconds

    Exp:
    Lot:

    64 fl/oz
    (1.89L)

    septodont

    Distributed by SEPTODONT
    416 S. Taylor Ave | Louisville, CO 80027
    800-872-8305 | www.septodontusa.com
    Made in the USA

    NDC#
    0362-6001-64

    Principal Display Panel - 1.89L Bottle Label

    PRINCIPAL DISPLAY PANEL - 0.5 L Bottle Label

    septodont

    SeptoSan

    Hand Sanitizer
    Enriched with Vitamins A & E

    Clinically Proven to Kill 99.99%
    of Germs in Seconds

    16.9 fl/oz
    (500 mL)

    septodont

    Distributed by SEPTODONT
    416 S. Taylor Ave | Louisville, CO 80027
    800-872-8305 | www.septodontusa.com
    Made in the USA

    Principal Display Panel - 0.5 L Bottle Label

    PRINCIPAL DISPLAY PANEL - 0.0148 L Bottle Label

    septodont

    SeptoSan

    Hand Sanitizer
    Enriched with Vitamins A & E

    Clinically Proven to Kill
    99.99% of Germs in Seconds

    0.5 fl/oz

    Sample not for resale

    septodont

    NDC# 0362-6002-05

    Distributed by SEPTODONT
    416 S. Taylor Ave | Louisville, CO 80027
    800-872-8305 | www.septodontusa.com

    Principal Display Panel - 0.0148 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    SEPTOSAN   HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0362-6001(NDC:68306-101)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol60 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Carbomer 1342 (UNII: 809Y72KV36)  
    Trolamine (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0362-6001-161.89 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/30/2010
    SEPTOSAN   HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0362-6000(NDC:68306-101)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol60 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Carbomer 1342 (UNII: 809Y72KV36)  
    Trolamine (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0362-6000-160.5 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/30/2010
    SEPTOSAN   HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0362-6002(NDC:68306-101)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol60 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Carbomer 1342 (UNII: 809Y72KV36)  
    Trolamine (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0362-6002-050.0148 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/30/2010
    Labeler - Septodont, Inc. (627058738)
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!