Antiseptic

Manufacturer
Safetec of America | Safetec of America, Inc.
Effective date
2011-06-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:28:20

Label at a glance#

ProductAntiseptic
Active ingredientisopropyl alcohol
Label structure9 sections

Indications and uses

For preparation of the skin prior to injection or venipuncture

Dosage and administration

start at the venipuncture site and apply in a circular fashion use additional wipes as necessary to cover area

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 71.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For preparation of the skin prior to injection or venipuncture

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame

Do not use with electrocautery procedures or in or near the eyes. If this happens, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • start at the venipuncture site and apply in a circular fashion
  • use additional wipes as necessary to cover area

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol, acetyl tributyl citrate, chloroxylenol

PRINCIPAL DISPLAY PANEL – packet label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL – packet label
PRINCIPAL DISPLAY PANEL – packet label

PRINCIPAL DISPLAY PANEL – box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

Contents: 50 individual, single-use, premoistened towelettes

NDC 61010-7000-1

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

PRINCIPAL DISPLAY PANEL – box
PRINCIPAL DISPLAY PANEL – box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1102259isopropyl alcohol 71.5 % Topical SolutionPSN4
1102259isopropyl alcohol 0.715 ML/ML Topical SolutionSCD4
1102259isopropyl alcohol 71.5 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-7000-12020-01-31C16284748780-19d75b9d0-0373-f424-e053-dadaa90a57ce4a0a404e-dfba-4df0-bc04-59a87502265b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-7000-0Antiseptic0.0012 L in 1 PACKETLIQUID0.00124
61010-7000-1Antiseptic50 in 1 BOXLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-7000ANTISEPTIC (ISOPROPYL ALCOHOL) LIQUID [SAFETEC OF AMERICA]4Legacy NDC, 2 package rows20110617_4a0a404e-dfba-4df0-bc04-59a87502265b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
isopropyl alcoholACTIVE INGREDIENTND2M4163024
isopropyl alcoholACTIVE MOIETYND2M4163024
acetyltributyl citrateINACTIVE INGREDIENT0ZBX0N59RZ4
alcoholINACTIVE INGREDIENT3K9958V90M4
chloroxylenolINACTIVE INGREDIENT0F32U78V2Q4
waterINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-700061010-7000-0, 61010-7000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

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 2 · 69 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, COATED / ORAL11 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZSOLUTION / TOPICAL5.4 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, DELAYED RELEASE / ORAL122 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE / ORAL7 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QSOLUTION / AURICULAR (OTIC)0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QCREAM / TOPICAL0.15 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET / ORAL150 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, EXTENDED RELEASE / ORAL309 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 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
188fff36-2829-4077-8115-bb90e0c25bbb4a0a404e-dfba-4df0-bc04-59a87502265b2011-06-09WarningsExact identifier
spl id: 188fff36-2829-4077-8115-bb90e0c25bbb
spl set id: 4a0a404e-dfba-4df0-bc04-59a87502265b

Reported adverse events (FAERS/openFDA)#

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