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Distributed by SEPTODONT
416 S. Taylor Ave | Louisville, CO 80027
800-872-8305 | www.septodontusa.com
Made in the USA
Septosan
FDA Label NDC 0362-6000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Septodont, Inc. for the product Septosan (NDC 0362-6000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - When Using
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.
Otc - Stop Use
If irritation develops, discontinue use.
Otc - Ask Doctor
If condition persists, consult a physician.
Otc - Keep Out Of Reach Of Children
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
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)
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