FDA.reportPublic FDA data

MEDPURA Hand Sanitizer Topical Solution

Manufacturer
Akron Pharma Inc | SLV Pharmaceuticals LLC
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:40:24

Label at a glance#

ProductMEDPURA Hand Sanitizer Topical Solution
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 0 -30 0 C (59 0 -86 0 F) Avoid freezing and excessive heat above 40 0 C (104 0 F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. 

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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 thoroughly with water.

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 (1-800-222-1222) 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 0-30 0C (59 0-86 0F)
  • Avoid freezing and excessive heat above 40 0C (104 0F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Ph: 1-877-225-6999

Mfg Lic. No: TN/DRUGS/558/1997

Manufactured for:

Akron Pharma Inc.

373 RT US 46W Building E,

Suite 117, Fairfield, NJ 07004

P: +1(877) 225-6999

    +1(973) 227-2000

www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical SolutionTopical Solution

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-2929-12023-01-30C16284748780-1f386c649-ede6-0266-e053-dadaa90a7c1aMEDPURA Hand Sanitzer Topical Solution Non-sterile
71399-2929-22023-01-30C16284748780-1f386c649-ede6-0266-e053-dadaa90a7c1aMEDPURA Hand Sanitzer Topical Solution Non-sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-2929-1MEDPURA Hand Sanitizer Topical Solution100 mL in 1 BOTTLESOLUTION1004
71399-2929-2MEDPURA Hand Sanitizer Topical Solution200 mL in 1 BOTTLESOLUTION2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-2929MEDPURA HAND SANITIZER TOPICAL SOLUTION (ISOPROPYL ALCOHOL) SOLUTION [AKRON PHARMA INC]4Legacy NDC, 2 package rows20210519_722b66b3-db12-431f-ae81-5fb0082f8505.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-2929-1ML - Milliliter71399-29297ab4f431-f703-4b78-bcd7-b9215246f2c412021-08-05
71399-2929-2ML - Milliliter71399-29297ebbb7e6-7724-4bf1-9e3a-4137a1d7c9ef12021-08-05

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
71399-292971399-2929-1, 71399-2929-2

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
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
c29e22fc-9a34-30fd-e053-2a95a90ae509722b66b3-db12-431f-ae81-5fb0082f85052021-05-18WarningsExact identifier
spl id: c29e22fc-9a34-30fd-e053-2a95a90ae509
spl set id: 722b66b3-db12-431f-ae81-5fb0082f8505

Reported adverse events (FAERS/openFDA)#

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