FDA.reportPublic FDA data

Alcohol

Manufacturer
Sion Biotext Medical Ltd | Sion Biotext Mexico SAPI de CV
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:08

Label at a glance#

ProductAlcohol
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes and burns For preparation of the skin prior to an injection

Dosage and administration

When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first. When used to prepare an injection site: Apply product to the injection site prior to injection.

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

First aid to help prevent infection in minor cuts, scrapes and burns

For preparation of the skin prior to an injection

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from flame or fire

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or over large areas of the body
  • longer than 1 week unless directed by doctor
  • with electrocautery procedures

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

Stop use an ask a doctor if

OTC - STOP USE SECTION

conditions persists for more than 72 hours or gets worse

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:

DOSAGE & ADMINISTRATION SECTION

  • When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • When used to prepare an injection site: Apply product to the injection site prior to injection.

Other Information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68786-300-01

4'' saturated

50 individual packs

LabelLabel

NDC 68786-300-02

4" saturated

3 per packet

25 packet

Label 1Label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD7
797544isopropyl alcohol 70 % Medicated PadSY7
797544isopropyl alcohol 70 % Topical ClothSY7
797544isopropyl alcohol 70 % Topical SwabSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-300-01Alcohol50 in 1 BOXSWAB507
68786-300-01Alcohol10 in 1 CASESWAB107
68786-300-02Alcohol75 in 1 BOXSWAB757
68786-300-02Alcohol10 in 1 CASESWAB107

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
68786-30068786-300-01, 68786-300-02

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-01-24full-release2026-06-01 00:07:50

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 Ltd7786a427-ac2b-46ed-b98e-3f2b22e15d2f2026-01-08WarningsExact identifier
ndc (package): 68786-300-01
ndc (package): 68786-300-02
ndc (product): 68786-300
ndc11 (package): 68786030002
ndc11 (package): 68786030001
spl id: 47e7c947-aa54-300c-e063-6294a90a091a
spl set id: 7786a427-ac2b-46ed-b98e-3f2b22e15d2f

Reported adverse events (FAERS/openFDA)#

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