FDA.reportPublic FDA data

Alcohol

Manufacturer
Dynarex Corporation
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:26:53

Label at a glance#

ProductAlcohol
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Stop use and ask a doctor if: Irritation or redness develops condition persists for more than 72 hours Cleansing of an injection site

Dosage and administration

Wipe injection site vigorously and discard

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic

Use:

OTC - PURPOSE SECTION

For preparation of the skin prior to injection.

Warnings:

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes

Indications and Usage:

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredient

  • Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1203 BX Master1203 BX Master1204 BX Master1204 BX Master1203 Alcohol Swabstick 67777-300-01

1204 Alcohol Swabstick 67777-300-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN11
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD11
797544isopropyl alcohol 70 % Medicated PadSY11
797544isopropyl alcohol 70 % Topical ClothSY11
797544isopropyl alcohol 70 % Topical SwabSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784120423GTIN-13: 0616784120423
EAN-13: 0616784120423
GTIN-12: 616784120423
UPC-A: 616784120423
GTIN storage (14 digits): 00616784120423		1204 BX MASTER.jpg
QR code linkQR Codedynarex.com/symbols.php1204 BX MASTER.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-300-01Alcohol10 in 1 CASESWAB1011
67777-300-01Alcohol50 in 1 BOXSWAB5011
67777-300-02Alcohol75 in 1 BOXSWAB7511
67777-300-02Alcohol10 in 1 CASESWAB1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-300-01EA - Each67777-300d4c55fb8-527a-408e-bbcf-be6b104b704c22023-09-05
67777-300-02EA - Each67777-3000a34d86b-dc39-47c9-8212-01bcba5b013d22023-09-05
67777-300-10EA - Each67777-300653d0f0d-7ca1-4efe-81dd-21e8bc92e52112024-02-14
67777-300-12EA - Each67777-3006e43f9e6-1893-4398-a0a4-1a361fe590b312024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163023
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

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
67777-30067777-300-01, 67777-300-02

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
AlcoholALCOHOLDynarex Corporation88c5dcbe-185f-4966-b98b-25d50299e8df2025-12-18WarningsExact identifier
ndc (package): 67777-300-02
ndc (package): 67777-300-01
ndc (product): 67777-300
ndc11 (package): 67777030002
ndc11 (package): 67777030001
spl id: 46477448-a1ca-d30e-e063-6394a90a612f
spl set id: 88c5dcbe-185f-4966-b98b-25d50299e8df

Reported adverse events (FAERS/openFDA)#

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