FDA.reportPublic FDA data

Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil

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 00:04:56

Label at a glance#

ProductSunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

apply freely and rub briskly with hands or towel.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% 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.
  • Use in well ventilated area, fumes may be harmful.

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 or mucous membranes.
  • do not apply to irritated skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

excessive irritation of the skin develops.

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

  • apply freely and rub briskly with hands or towel.

Other Information

OTHER SAFETY INFORMATION

  • does not contain ethyl or grain alcohol and is not sold as a substitute for preparations containing the same.
  • Store at controlled room temperature
  • will produce serious gastric disturbances if taken internally.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Methyl salicylate 0.5%

FDC Blue #1

FDC Yellow #5

bitrex

purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SM70W.jpgSM70W.jpgNDC 49348-175-38

isopropyl

rubbing

alcohol

70% USP

Wintergreen

16 FL OZ (1 PT) 473 mL

Principal Display Panel NDC 49348-175-38 isopropyl rubbing alcohol 70% USP Wintergreen 16 FL OZ (1 PT) 473 mLPrincipal Display Panel NDC 49348-175-38 isopropyl rubbing alcohol 70% USP Wintergreen 16 FL OZ (1 PT) 473 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN6
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD6
808520isopropyl alcohol 70 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-175-38Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil473 mL in 1 BOTTLELIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-175SUNMARK ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL (ISOPROPYL ALCOHOL) LIQUID [STRATEGIC SOURCING SERVICES LLC]6Current NDC, Legacy NDC, 1 package rows20231220_515dd733-1b44-4df0-928f-a3b202b5f9c2.zip

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
49348-17549348-175-38

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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 70 Percent With Wintergreen OilISOPROPYL ALCOHOLStrategic Sourcing Services LLC515dd733-1b44-4df0-928f-a3b202b5f9c22023-12-19WarningsExact identifier
ndc (package): 49348-175-38
ndc (product): 49348-175
ndc11 (package): 49348017538
spl id: 0ce57040-019d-0c43-e063-6394a90a52eb
spl set id: 515dd733-1b44-4df0-928f-a3b202b5f9c2

Reported adverse events (FAERS/openFDA)#

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