PyurX

Manufacturer
Novara LLC | Huizhou Duomei Daily Necessites Co., LTD.
Effective date
2020-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:55

Label at a glance#

ProductPyurX
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product in your palm to cover hands and rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110F (43C) May discolor certain fabrics or surfaces

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. Isopropyl Alcohol (75%, 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.

See ingreditents list for accurate list.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
  • Do not use on children less than 2 months of age.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Irritation and rednessdevelop and persist for more than 72 hours.
    • Swallowed, get medical help or contact a poison control centerright away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua(Water), Glycerin, Carbomer, Triethanolamine, Aloe, Tocopheryl Acetate (Vitamin E).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml. NDC: 80527-251-50 Front LabelFront Label Back LabelBack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80527-251-502022-01-28C16284748780-1d6a99b39-c949-a426-e053-dadaa90af4c2aeeb47a7-0b21-093e-e053-2a95a90abef9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80527-251-50PyurX500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80527-251PYURX (ETHANOL ALCOHOL) GEL [NOVARA LLC]1Legacy NDC, 1 package rows20200910_aeeb47a7-0b21-093e-e053-2a95a90abef9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80527-25180527-251-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
aeeb7c2e-240c-53aa-e053-2a95a90adf9caeeb47a7-0b21-093e-e053-2a95a90abef92020-09-09WarningsExact identifier
spl id: aeeb7c2e-240c-53aa-e053-2a95a90adf9c
spl set id: aeeb47a7-0b21-093e-e053-2a95a90abef9

Reported adverse events (FAERS/openFDA)#

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