FDA.reportPublic FDA data

VanRex Alcohol Antiseptic

Manufacturer
Aromaquest Systems, LLC.
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:21:45

Label at a glance#

ProductVanRex Alcohol Antiseptic
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Skin rub to help reduce bacteria that potencially can cause disease.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Skin rub to help reduce bacteria that potencially can cause disease.

Warning

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl alcohol.

Package Labeling:475ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:240ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:3785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79765-00079765-000-01, 79765-000-02, 79765-000-03, 79765-000-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALCOHOL3K9958V90MACTIB

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
d398fa9c-f2eb-7fbc-e053-2995a90a7d3dacaf3b6a-4e9e-dbe7-e053-2995a90af5082021-12-20WarningsExact identifier
spl id: d398fa9c-f2eb-7fbc-e053-2995a90a7d3d
spl set id: acaf3b6a-4e9e-dbe7-e053-2995a90af508

Reported adverse events (FAERS/openFDA)#

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