FDA.reportPublic FDA data

Purexx 75% IPA Hand Sanitizer

Manufacturer
SanitizeNow Inc.
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:59

Label at a glance#

ProductPurexx 75% IPA Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Isopropyl Alcohol (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin
Isopropyl Myristate 0% to < 0.25%
Propylene Glycol
Carbomer and/or acrylates/alkyl polymers
Aloe Arborescens Leaf
Tocopheryl Acetate
Fragrance

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

208 L NDC: 74988-735-55 drumdrum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74988-735-552022-01-28C16284748780-1d6a99b39-4a12-a426-e053-dadaa90af4c2b34bf1e7-ac8f-dcb0-e053-2995a90ae55a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74988-735-55Purexx 75% IPA Hand Sanitizer208000 mL in 1 DRUMGEL2080001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74988-735PUREXX 75% IPA HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [SANITIZENOW INC.]1Legacy NDC, 1 package rows20201105_b34bf1e7-ac8f-dcb0-e053-2995a90ae55a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74988-73574988-735-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOE ARBORESCENS LEAF09TD8L5SQVIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

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
b34bf1e7-ac81-dcb0-e053-2995a90ae55ab34bf1e7-ac8f-dcb0-e053-2995a90ae55a2020-11-04WarningsExact identifier
spl id: b34bf1e7-ac81-dcb0-e053-2995a90ae55a
spl set id: b34bf1e7-ac8f-dcb0-e053-2995a90ae55a

Reported adverse events (FAERS/openFDA)#

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