SEPTOSAN HAND SANITIZER- alcohol liquid

SeptoSan by

Drug Labeling and Warnings

SeptoSan by is a Otc medication manufactured, distributed, or labeled by Septodont, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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 - 0.0148 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

INGREDIENTS AND APPEARANCE

SEPTOSAN   HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0362-6001(NDC:68306-101)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	60 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0362-6001-16	1.89 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	09/30/2010

SEPTOSAN   HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0362-6000(NDC:68306-101)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	60 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0362-6000-16	0.5 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	09/30/2010

SEPTOSAN   HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0362-6002(NDC:68306-101)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	60 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0362-6002-05	0.0148 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	09/30/2010

Labeler - Septodont, Inc. (627058738)