FDA.reportPublic FDA data

Isopropyl Alcohol 70 Percent With Wintergreen Oil

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:44

Label at a glance#

ProductIsopropyl Alcohol 70 Percent With Wintergreen Oil
Active ingredientISOPROPYL ALCOHOL
Label structure14 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

purified water

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPWinter.jpgGNPWinter.jpgPrincipal Display Panel NDC 46122-331-43 ISOPROPYL RUBBING ALCOHOL 70% With Wintergreen Oil Rubbing, Massage, Sponge Bath 16 fl oz (1 pt) 473 mLPrincipal Display Panel NDC 46122-331-43 ISOPROPYL RUBBING ALCOHOL 70% With Wintergreen Oil Rubbing, Massage, Sponge Bath 16 fl oz (1 pt) 473 mL

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMSM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2
808520isopropyl alcohol 70 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-915-16Isopropyl Alcohol 70 Percent With Wintergreen Oil473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-915ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL (ISOPROPYL ALCOHOL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42f6c6d-c4e1-02c6-e053-2995a90a3ace.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
82645-91582645-915-16

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
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
ndc (package): 82645-915-16
ndc (product): 82645-915
ndc11 (package): 82645091516
spl id: 0d6ccefd-6382-35fb-e063-6294a90adf31
spl set id: e42f6c6d-c4e1-02c6-e053-2995a90a3ace

Reported adverse events (FAERS/openFDA)#

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