FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Swabplus Inc. | Swabplus Inc
Effective date
2015-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:43

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.

Dosage and administration

Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.

Storage and handling

Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

ISOPROPYL ALCOHOL 70%

Purpose

OTC - PURPOSE SECTION

for Antiseptic

Uses

OTC - WHEN USING SECTION

Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

  • Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other.
  • Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
  • Apply the product to the affected area.
  • Discard swab after use.

Warnings

WARNINGS SECTION

  • For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
  • Do not use. longer than one week unless directed  by a doctor.
  • Stop use and ask a doctor if you have deep or puncture wounds, or serious burns, redness, irritation, swelling or pain continues or increase, infection occurs.

Administration

DOSAGE & ADMINISTRATION SECTION

  • For adult and children 2 and older:Clean affected area and apply 1 to 3 times daily. May be covered with a bandage.
  • Children under 2 years of age: Do not use, consult a doctor. 

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Patent

STATEMENT OF IDENTITY SECTION

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 Made in USA

The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

Package and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Isopropyl Alcohol Label

image of Isopropyl Alcohol Labelimage of Isopropyl Alcohol Label

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
65734-001-242020-01-31C16284748780-19d75b9cf-d5cb-f424-e053-dadaa90a57ceIsopropyl Alcohol 70% Filled Swab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65734-001-00Isopropyl Alcohol0.15 mL in 1 APPLICATORSOLUTION0.151
65734-001-24Isopropyl Alcohol24 in 1 PACKETSOLUTION241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65734-001ISOPROPYL ALCOHOL SOLUTION [SWABPLUS INC.]1Legacy NDC, 2 package rows20151001_1ff7845d-37a1-4a54-96a0-fe64eb2ab731.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65734-00165734-001-00, 65734-001-24

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
ISOPROPYL ALCOHOLND2M416302ACTIB
Water059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
84b830cf-b025-4864-aef5-6db67b88bb151ff7845d-37a1-4a54-96a0-fe64eb2ab7312015-02-13WarningsExact identifier
spl id: 84b830cf-b025-4864-aef5-6db67b88bb15
spl set id: 1ff7845d-37a1-4a54-96a0-fe64eb2ab731

Reported adverse events (FAERS/openFDA)#

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