SEPTOSAN  HAND SANITIZER- alcohol liquid 
Septodont, Inc.

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.

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SeptoSan
Hand Sanitizer

Drug Facts

Active Ingredient

Ethanol 60%

Purpose

Antiseptic

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.

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

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
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)

Revised: 10/2010
Document Id: f019f064-2265-4ba6-be5d-7771f1e524d5
Set id: edc3ebff-3ad0-48b6-83e0-849620cf9751
Version: 1
Effective Time: 20101006
 
Septodont, Inc.