FDA.reportPublic FDA data

Sunmark Isopropyl Alcohol 91 Percent

Manufacturer
Strategic Sourcing Services LLC | Pharma Nobis, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:58

Label at a glance#

ProductSunmark Isopropyl Alcohol 91 Percent
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

clean the affected area. apply a small amount of this product on the affected area 1 to 3 times daily. may be covered with sterile bandage. if bandaged, let it dry first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 91% by volume

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in.

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only.

  • Flammable, keep way from spark, heat and flame.

Ask a doctor before use for

OTC - ASK DOCTOR SECTION

  • deep wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. 
  • do not apply over large areas of the body
  • do not use longer than 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

If condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area.
  • apply a small amount of this product on the affected area 1 to 3 times daily.
  • may be covered with sterile bandage.
  • if bandaged, let it dry first.

Other Information

OTHER SAFETY INFORMATION

  • store at controlled room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol.
  • will produce serious gastric disturbances if taken internally.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SM91.jpgSM91.jpg

Principal Display Panel NDC 49348-174-38 isopropyl rubbing alcohol 91% USP 16 FL OZ (1 PT) 473 mLPrincipal Display Panel NDC 49348-174-38 isopropyl rubbing alcohol 91% USP 16 FL OZ (1 PT) 473 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN6
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD6
582901isopropyl alcohol 91 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-174-38Sunmark Isopropyl Alcohol 91 Percent473 mL in 1 BOTTLELIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-174SUNMARK ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [STRATEGIC SOURCING SERVICES LLC]6Current NDC, Legacy NDC, 1 package rows20231220_92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-174-38ML - Milliliter49348-1749ba8a674-495f-482e-bdac-22aed60aac5512017-04-05

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-17449348-174-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

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
Sunmark Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLC92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e2023-12-19WarningsExact identifier
ndc (package): 49348-174-38
ndc (product): 49348-174
ndc11 (package): 49348017438
spl id: 0ce5731a-7e20-654e-e063-6294a90a2b5c
spl set id: 92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e

Reported adverse events (FAERS/openFDA)#

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