FDA.reportPublic FDA data

BENEMAX

Manufacturer
Nugale Pharmaceutical Inc
Effective date
2021-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:10

Label at a glance#

ProductBENEMAX
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Indications and uses

as a hand sanitizer when there is no water, to reduce bacteria on the skin which can cause illness. Recommended for repeated use.

Dosage and administration

spray 3·5 pumps of hand sanitizer onto hands or enough to thoroughly cover hands. children under 6 years of age must be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70%, USP

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

as a hand sanitizer when there is no water, to reduce bacteria on the skin which can cause illness. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • in case of contact, rinse eyes thoroughly with water

Stop use and cantact your doctor

OTC - STOP USE SECTION

if a rash on irritation appear and remain at the site of contact

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray 3·5 pumps of hand sanitizer onto hands or enough to thoroughly cover hands.
  • children under 6 years of age must be supervised when using this product.

Other information

SPL UNCLASSIFIED SECTION

  • do not store above 110 0F (43 0C). May discolor certain fabrics or substances

Inactive ingredient

INACTIVE INGREDIENT SECTION

aloe juice (aloe barbadensis), carbomer 940NF, di-alpha-tocopheryl acetate, triethanolamine, glycerin

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014638isopropyl alcohol 70 % Topical SprayPSN4
1014638isopropyl alcohol 0.7 ML/ML Topical SpraySCD4
1014638isopropyl alcohol 70 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73700-001-012023-01-30C16284748780-1f386c64a-21a1-0266-e053-dadaa90a7c1aDrug Facts
73700-001-022023-01-30C16284748780-1f386c64a-21a1-0266-e053-dadaa90a7c1aDrug Facts
73700-001-032023-01-30C16284748780-1f386c64a-21a1-0266-e053-dadaa90a7c1aDrug Facts
73700-001-042023-01-30C16284748780-1f386c64a-21a1-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73700-001-01BENEMAX60 mL in 1 BOTTLE, SPRAYLIQUID604
73700-001-02BENEMAX60 mL in 1 BOTTLELIQUID604
73700-001-03BENEMAX236 mL in 1 BOTTLELIQUID2364
73700-001-04BENEMAX1000 mL in 1 BOTTLELIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73700-001BENEMAX (ISOPROPYL ALCOHOL 70%) LIQUID [NUGALE PHARMACEUTICAL INC]4Legacy NDC, 4 package rows20211130_9d630406-b216-4dbe-ab4e-29c5a07e6b54.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73700-00173700-001-01, 73700-001-02, 73700-001-03, 73700-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
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
d1f15a7c-be04-03e4-e053-2995a90a63099d630406-b216-4dbe-ab4e-29c5a07e6b542021-11-29WarningsExact identifier
spl id: d1f15a7c-be04-03e4-e053-2995a90a6309
spl set id: 9d630406-b216-4dbe-ab4e-29c5a07e6b54

Reported adverse events (FAERS/openFDA)#

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