FDA.reportPublic FDA data

alcohol

Manufacturer
Sion Biotext Medical Ltd
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:35

Label at a glance#

Productalcohol
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

For preparation of skin prior to an injection

Dosage and administration

Wipe injection site vigorously and discard.

Storage and handling

Avoid excessive heat Store at room temperature 15 o ​-30 o C (59 o -86 o F)

Label contents#

Full prescribing information#

​Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v                         

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For preparation of skin prior to an injection

Warnings:

WARNINGS SECTION

  • For External Use Only
  • Flammable, keep away from fire or flame
  • Sterile unless pouch is opened or damaged

Do not use:

OTC - DO NOT USE SECTION

  • With electrocautery procedures
  • In the eyes.

Stop use and ask a doctor:

OTC - STOP USE SECTION

  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Wipe injection site vigorously and discard.

Other Information

STORAGE AND HANDLING SECTION

  • Avoid excessive heat
  • Store at room temperature 15 o​-30 o C (59 o-86 o F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68786-120-13

Sion Biotext Medical Ltd.

Alcohol Prep Pad

Sterile- Medium 2 Ply

One pad saturated with 70% Isopropyl Alcohol

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN10
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD10
797544isopropyl alcohol 70 % Medicated PadSY10
797544isopropyl alcohol 70 % Topical ClothSY10
797544isopropyl alcohol 70 % Topical SwabSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-120-13alcohol10 in 1 CASESWAB1010
68786-120-13alcohol200 in 1 BOXSWAB20010
68786-120-14alcohol20 in 1 CASESWAB2010
68786-120-14alcohol100 in 1 BOXSWAB10010
68786-120-16alcohol100 in 1 BOXSWAB10010
68786-120-16alcohol10 in 1 CASESWAB1010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163024
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163024
WATERINACTIVE INGREDIENT059QF0KO0R4

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
68786-12068786-120-14, 68786-120-13, 68786-120-16

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-01-10full-release2026-06-01 00:06:58

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
alcoholALCOHOLSion Biotext Medical Ltd671e9fa9-a4b8-42a2-bd6f-490bc902a86e2026-01-08WarningsExact identifier
ndc (package): 68786-120-13
ndc (package): 68786-120-14
ndc (package): 68786-120-16
ndc (product): 68786-120
ndc11 (package): 68786012014
ndc11 (package): 68786012016
ndc11 (package): 68786012013
spl id: 47e7cac8-63dd-eced-e063-6394a90a9ba3
spl set id: 671e9fa9-a4b8-42a2-bd6f-490bc902a86e

Reported adverse events (FAERS/openFDA)#

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