FDA.reportPublic FDA data

TRISEPTIN Hand and Body Antiseptic – alcohol lotion CareFusion

Manufacturer
HEALTHPOINT, LTD | DPT LABORATORIES, LTD
Effective date
2012-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:34

Label at a glance#

ProductTRISEPTIN HAND AND BODY ANTISEPTIC
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Surgical Hand Scrub: Significantly reduces the number of microorganisms on the hands, forearms and body prior to surgery or patient care. Patient Preoperative Skin Preparation: For preparation of the skin prior to surgery or an injection. Helps reduce bacteria that can potentially cause skin infection.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Surgical Hand Scrub:

  • Significantly reduces the number of microorganisms on the hands, forearms and body prior to surgery or patient care.

Label section

Patient Preoperative Skin Preparation:

  • For preparation of the skin prior to surgery or an injection.
  • Helps reduce bacteria that can potentially cause skin infection.

Warnings

WARNINGS SECTION

  • Flammable, keep away from fire or flame.
  • For external use only.
  • Do not use
  • if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
  • on or near the eyes, mucous membranes, genital skin, or mouth. If product gets into the eyes, flush immediately with water.
  • Avoid contact with broken skin.
  • Stop use and ask doctor if irritation and redness develop. If condition persists for more than 72 hours consult a physician.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Surgical Hand Scrub:

  • Clean under nails with a nail pick. Nails should be maintained with a 1 mm free edge.
  • Wet hands and forearms.
  • Dispense palmful (approx. 7 ml) of TRISEPTIN Scrub into the palm of one hand.
  • Twist fingertips of the opposite hand, working TRISEPTIN under the nails.
  • Transfer TRISEPTIN to the opposite hand and repeat with fingertips of the other hand.
  • Rub TRISEPTIN over the hands and up the forearms to just past the elbow, paying particular attention to the nails, cuticles and interdigital spaces for 90 seconds.
  • Rinse and repeat the procedure to just below the elbows. Rinse completely.

Patient Preoperative Skin Preparation:

  • Apply to cleanse the surgical site and surrounding area 12 hours and 6 hours prior to surgery.
  • Clean the surgical area.
  • Place a palmful (approx. 7 ml) of TRISEPTIN to the surgical site and surrounding area and rub for 90 seconds paying particular attention to the surgical area.
  • Rinse and repeat.
  • Rinse completely.

DOSAGE & ADMINISTRATION SECTION

Other information

  • Store at 20-25º C (68-77º F).
  • Avoid freezing and excessive heat.
  • Protect from light until use.
  • Shake well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzethonium chloride, citric acid, cocamine oxide, fragrance, glyceryl laurate, hydroxypropylcellulose, phenylethyl alcohol, phosphoric acid, polyoxyl 40 stearate, propyl gallate, propylene glycol, purified water, zinc pyrithione.

Questions?

Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.triseptin.com.

Marketed by:
CareFusion
Leawood, KS 66211

Manufactured for:
Healthpoint, Ltd.
Fort Worth, TX 76107
by DPT Laboratories, Ltd.
San Antonio, Texas 78215

REORDER NO. 0064-1050-04
PATENT NO. 6,110,908

4 fl oz (118 ml)
129478-0411

PRINCIPAL DISPLAY PANEL

NDC 0064-1050-04

Triseptin®
Ethyl alcohol 70% v/v
Hand & Body Antiseptic

Surgical Hand Scrub

  • Used by surgeons in hospital operating rooms

Patient Preoperative Skin Preparation

  • Helps reduce bacteria that can potentially cause skin infection
  • Alcohol and other skin-conditioning ingredients
  • Fast antibacterial action

4 fl oz
(118 ml)
129477-0411

CareFusion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

39ef369b-figure-01
39ef369b-figure-01
39ef369b-figure-02
39ef369b-figure-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098175ethanol 70 % Medicated Liquid SoapPSN2
1098175ethanol 0.7 ML/ML Medicated Liquid SoapSCD2
1098175ethanol 70 % Medicated Liquid SoapSY2
1098175ethyl alcohol 70 % Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0064-1050-042020-01-31C16284748780-19d75b9d0-589c-f424-e053-dadaa90a57ceTRISEPTIN Hand and Body Antiseptic – alcohol lotion CareFusion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0064-1050-04TRISEPTINHAND AND BODY ANTISEPTIC118 mL in 1 BOTTLE, PLASTICLOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0064-1050TRISEPTIN HAND AND BODY ANTISEPTIC (ALCOHOL) LOTION [HEALTHPOINT, LTD]2Legacy NDC, 1 package rows20120109_757aed4e-43b9-4361-83bb-3fc4a6688d31.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M2
ALCOHOLACTIVE MOIETY3K9958V90M2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057442
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
COCAMINE OXIDEINACTIVE INGREDIENTQWA2IZI6FI2
GLYCERYL LAURATEINACTIVE INGREDIENTY98611C0872
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA74682
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9I2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V922
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PYRITHIONE ZINCINACTIVE INGREDIENTR953O2RHZ52
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0064-10500064-1050-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BENZETHONIUM CHLORIDEPH41D05744IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMINE OXIDEQWA2IZI6FIIACT
GLYCERYL LAURATEY98611C087IACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5IACT

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 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, EXTENDED RELEASE / ORAL204 mgExact identifier — unii candidate
27 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii candidate
27 equally ranked IID candidates
PHENYLETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SUSPENSION / INTRAMUSCULAR5 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, CHEWABLE / ORAL10 mgExact identifier — unii candidate
27 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, FILM COATED, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92OINTMENT / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
27 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ICREAM / TOPICAL86000 mgExact identifier — unii candidate
13 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAVENOUS1 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENYLETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SOLUTION / AURICULAR (OTIC)0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHENYLETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SPRAY / NASAL1 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92GEL / TOPICAL0.05 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL LAURATEGLYCERYL LAURATEY98611C087SYSTEM / TOPICAL4 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNOINTMENT / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PFILM / BUCCAL87 mgExact identifier — unii candidate
27 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 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
39ef369b-8e81-442a-9e31-55ee8b2585bf757aed4e-43b9-4361-83bb-3fc4a6688d312012-01-04WarningsExact identifier
spl id: 39ef369b-8e81-442a-9e31-55ee8b2585bf
spl set id: 757aed4e-43b9-4361-83bb-3fc4a6688d31

Reported adverse events (FAERS/openFDA)#

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