FDA.reportPublic FDA data

SeptoSan

Manufacturer
Septodont, Inc.
Effective date
2010-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:18

Label at a glance#

ProductSeptoSan Hand Sanitizer
Active ingredientAlcohol
Label structure11 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 60%

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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 SECTION

If irritation develops, discontinue use.

OTC - ASK DOCTOR SECTION

If condition persists, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 1.89L Bottle Label

PRINCIPAL DISPLAY PANEL - 0.5 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 0.5 L Bottle Label

PRINCIPAL DISPLAY PANEL - 0.0148 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 0.0148 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039483ethanol 60 % Topical SolutionPSN1
1039483ethanol 0.6 ML/ML Topical SolutionSCD1
1039483ethanol 60 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0362-6000-162019-11-13C16284748780-197449f38-cc47-f6ea-e053-dbdaa90aa703SeptoSan Hand Sanitizer
0362-6001-162019-11-13C16284748780-197449f38-cc47-f6ea-e053-dbdaa90aa703SeptoSan Hand Sanitizer
0362-6002-052019-11-13C16284748780-197449f38-cc47-f6ea-e053-dbdaa90aa703SeptoSan Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-6000-16SeptoSan Hand Sanitizer0.5 L in 1 BOTTLE, PLASTICLIQUID0.51
0362-6001-16SeptoSan Hand Sanitizer1.89 L in 1 BOTTLE, PLASTICLIQUID1.891
0362-6002-05SeptoSan Hand Sanitizer0.0148 L in 1 BOTTLE, PLASTICLIQUID0.01481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-6000SEPTOSAN HAND SANITIZER (ALCOHOL) LIQUID [SEPTODONT, INC.]1Legacy NDC, 1 package rows20120403_edc3ebff-3ad0-48b6-83e0-849620cf9751.zip
0362-6001SEPTOSAN HAND SANITIZER (ALCOHOL) LIQUID [SEPTODONT, INC.]1Legacy NDC, 1 package rows20120403_edc3ebff-3ad0-48b6-83e0-849620cf9751.zip
0362-6002SEPTOSAN HAND SANITIZER (ALCOHOL) LIQUID [SEPTODONT, INC.]1Legacy NDC, 1 package rows20120403_edc3ebff-3ad0-48b6-83e0-849620cf9751.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
Carbomer 1342INACTIVE INGREDIENT809Y72KV361
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0362-60010362-6001-16
68306-101
0362-60000362-6000-16
0362-60020362-6002-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Carbomer 1342809Y72KV36IACT
Trolamine9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Carbomer 1342809Y72KV36IACT
Trolamine9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Carbomer 1342809Y72KV36IACT
Trolamine9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 184 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36EMULSION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36FILM, EXTENDED RELEASE / TRANSDERMAL38.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f019f064-2265-4ba6-be5d-7771f1e524d5edc3ebff-3ad0-48b6-83e0-849620cf97512010-10-06WarningsExact identifier
spl id: f019f064-2265-4ba6-be5d-7771f1e524d5
spl set id: edc3ebff-3ad0-48b6-83e0-849620cf9751

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.