FDA.reportPublic FDA data

Antiseptic

Manufacturer
ReliaMed | Safetec of America, Inc.
Effective date
2013-06-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:02:31

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

clean the area start at the venipuncture site and apply in a circular fashion using friction

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.

OTC - DO NOT USE SECTION

Do not use with electrocautery procedures or in or near the eyes. For external use only.

OTC - STOP USE SECTION

Stop use and ask a 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

  • clean the area
  • start at the venipuncture site and apply in a circular fashion using friction

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol SDA-40B, acetyl tributyl citrate, chloroxylenol

PRINCIPAL DISPLAY PANEL – packet label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REORDER NO. ZA50075

LATEX FREE

NDC 52641-700-02

ReliaMed

I.V.
Antiseptic Wipes

For preparation of the skin prior
to injection or venipuncture

Contains: One Wipe

Distributed by ReliaMed

Ft. Worth, TX 76106 1-800-409-2848

Made in the U.S.A. Rev 050611

TEAR HERE

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

PRINCIPAL DISPLAY PANEL – box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

ReliaMed

REORDER NO. ZA50075

LATEX FREE

NDC 52641-700-02

I.V. Antiseptic Wipes

For preparation of the skin prior to injection or venipuncture

75 Individual Wipes

  • Protect skin from adhesives
  • Non-irritating to intact skin
  • Thick, soft application padPRINCIPAL DISPLAY PANEL – box labelPRINCIPAL DISPLAY PANEL – box label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52641-700-012021-01-29C16284748780-1ba0f9c33-547a-a910-e053-dadaa90a0b85652c577e-17e7-42eb-b351-23fbc6757c26
52641-700-022021-01-29C16284748780-1ba0f9c33-547a-a910-e053-dadaa90a0b85652c577e-17e7-42eb-b351-23fbc6757c26

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52641-700-01Antiseptic1.2 mL in 1 PACKETLIQUID1.26
52641-700-01Antiseptic50 in 1 BOXLIQUID506
52641-700-02Antiseptic1.2 mL in 1 PACKETLIQUID1.26
52641-700-02Antiseptic75 in 1 BOXLIQUID756

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52641-700ANTISEPTIC (ISOPROPYL ALCOHOL) LIQUID [RELIAMED]6Legacy NDC, 4 package rows20191231_652c577e-17e7-42eb-b351-23fbc6757c26.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
isopropyl alcoholACTIVE INGREDIENTND2M4163025
isopropyl alcoholACTIVE MOIETYND2M4163025
acetyltributyl citrateINACTIVE INGREDIENT0ZBX0N59RZ5
alcoholINACTIVE INGREDIENT3K9958V90M5
chloroxylenolINACTIVE INGREDIENT0F32U78V2Q5
ethyl nitrateINACTIVE INGREDIENTE1ZT886LR55
waterINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52641-70052641-700-02, 52641-700-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
isopropyl alcoholND2M416302ACTIB
water059QF0KO0RIACT
alcohol3K9958V90MIACT
acetyltributyl citrate0ZBX0N59RZIACT
chloroxylenol0F32U78V2QIACT
ethyl nitrateE1ZT886LR5IACT

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 2 · 69 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, COATED / ORAL11 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QSOLUTION / AURICULAR (OTIC)0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QCREAM / TOPICAL0.15 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, DELAYED RELEASE / ORAL122 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE / ORAL7 mgExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, EXTENDED RELEASE / ORAL309 mgExact identifier — unii candidate
8 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
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
acetyltributyl citrateACETYLTRIBUTYL CITRATE0ZBX0N59RZSOLUTION / TOPICAL5.4 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact 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
f15a2a41-5a22-4d74-a868-90b5b862c1b2652c577e-17e7-42eb-b351-23fbc6757c262013-06-10WarningsExact identifier
spl id: f15a2a41-5a22-4d74-a868-90b5b862c1b2
spl set id: 652c577e-17e7-42eb-b351-23fbc6757c26

Reported adverse events (FAERS/openFDA)#

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