Novapur Creamy Moisturizing Hand Sanitizer

Manufacturer
Les Entreprises Stefmar Inc
Effective date
2021-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:09

Label at a glance#

ProductNovapur Creamy Moisturizing Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Directions Supervise children when they use this product Rub thoroughly into hands for at least 30 seconds and allow to dry

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

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.15% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

For hand-washing to decrease bacteria on the skin, only when water is not available. For occasional personal domestic use.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 years old
  • on open wounds

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes.
  • if contact occurs, rinse thoroughly with water.

.

OTC - STOP USE SECTION

Stop use and ask a doctor if

irritation and redness develops.

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

Directions

  • Supervise children when they use this product
  • Rub thoroughly into hands for at least 30 seconds and allow to dry

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

Aqua, Caprylic/Capric Triglyceride, Propylene glycol, Phenoxyethanol, Sodium polyacrylate, Ethylhexylglycerin, Aloe barbadensis leaf juice, Tocopherol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novapur 500 mL LabelNovapur 500 mL Label

500 mL NDC: 71316-100-50

150 mL NDC: 71316-100-15 Novapur 150 mL LabelNovapur 150 mL Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71316-100-04Novapur Creamy Moisturizing Hand Sanitizer40 mL in 1 TUBEGEL401
71316-100-08Novapur Creamy Moisturizing Hand Sanitizer80 mL in 1 TUBEGEL801
71316-100-15Novapur Creamy Moisturizing Hand Sanitizer150 mL in 1 TUBEGEL1501
71316-100-50Novapur Creamy Moisturizing Hand Sanitizer500 mL in 1 BOTTLEGEL5001
71316-100-90Novapur Creamy Moisturizing Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
71316-100-95Novapur Creamy Moisturizing Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71316-100NOVAPUR CREAMY MOISTURIZING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [LES ENTREPRISES STEFMAR INC]1Legacy NDC, 6 package rows20210829_c915506a-01cc-ac70-e053-2a95a90a04ff.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71316-10071316-100-15, 71316-100-50, 71316-100-04, 71316-100-08, 71316-100-90, 71316-100-95

Ingredients#

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

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

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
c915506a-01be-ac70-e053-2a95a90a04ffc915506a-01cc-ac70-e053-2a95a90a04ff2021-08-08WarningsExact identifier
spl id: c915506a-01be-ac70-e053-2a95a90a04ff
spl set id: c915506a-01cc-ac70-e053-2a95a90a04ff

Reported adverse events (FAERS/openFDA)#

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