Pyroxy Liquid-80B

Manufacturer
Pyrock Chemical | Reflow Supply Chain Solutions LLC
Effective date
2022-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:47

Label at a glance#

ProductPyroxy Liquid-80B
Active ingredientALCOHOL
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

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

Alcohol 80% 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front 3785.41 ml - NDC 78517-801-01

Front 3785.41 ml - NDC 78517-801-01Front 3785.41 ml - NDC 78517-801-01Back 3785.41 ml - NDC 78517-801-01

Back 3785.41 ml - NDC 78517-801-01Back 3785.41 ml - NDC 78517-801-01Front 18927.05 ml - NDC 78517-801-95

Front 18927.05 ml - NDC 78517-801-95Front 18927.05 ml - NDC 78517-801-95Back 18927.05 ml - NDC 78517-801-95

​Back 18927.05 ml - NDC 78517-801-95​Back 18927.05 ml - NDC 78517-801-95Front 208197.65 ml - NDC 78517-801-55

​Front 208197.65 ml - NDC 78517-801-55​Front 208197.65 ml - NDC 78517-801-55​Back 208197.65 ml - NDC 78517-801-55

​​Back 208197.65 ml - NDC 78517-801-55​​Back 208197.65 ml - NDC 78517-801-55Front 250 ml - NDC 78517-801-92

​Front 250 ml - NDC 78517-801-92​Front 250 ml - NDC 78517-801-92​Back 250 ml - NDC 78517-801-92

​​Back 250 ml - NDC 78517-801-92​​Back 250 ml - NDC 78517-801-92Front 1040988.2 ml - NDC 78517-801-27

Front 1040988.2 ml - NDC 78517-801-27Front 1040988.2 ml - NDC 78517-801-27Back 1040988.2 ml - NDC 78517-801-27

​Back 1040988.2 ml - NDC 78517-801-27​Back 1040988.2 ml - NDC 78517-801-27Front 1249185.9 ml - NDC 78517-801-33

Front 1249185.9 ml - NDC 78517-801-33Front 1249185.9 ml - NDC 78517-801-33

Back 1249185.9 ml - NDC 78517-801-33

Back 1249185.9 ml - NDC 78517-801-33Back 1249185.9 ml - NDC 78517-801-33Front 1000 ml - NDC 78517-801-91

​Front 1000 ml - NDC 78517-801-91​Front 1000 ml - NDC 78517-801-91​Back 1000 ml - NDC 78517-801-91

​Back 1000 ml - NDC 78517-801-91​Back 1000 ml - NDC 78517-801-91Front 25362259 ml - NDC 78517-801-67

​Front 25362259 ml - NDC 78517-801-67​Front 25362259 ml - NDC 78517-801-67​Back 25362259 ml - NDC 78517-801-67

​Back 25362259 ml - NDC 78517-801-67​Back 25362259 ml - NDC 78517-801-67

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78517-801-012024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-272024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-332024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-552024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-672024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-912024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-922024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-952024-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-012022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-272022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-332022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-552022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-672022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-912022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-922022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-952022-01-30C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-012022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-272022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-332022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-552022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-672022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-912022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-922022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%
78517-801-952022-01-28C16284748780-1d6a99b39-a989-a426-e053-dadaa90af4c2Pyroxy Liquid-80B - 80%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78517-801-01Pyroxy Liquid-80B3785.41 mL in 1 BOTTLELIQUID3785.412
78517-801-27Pyroxy Liquid-80B1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1040988.22
78517-801-33Pyroxy Liquid-80B1249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1249185.92
78517-801-55Pyroxy Liquid-80B208197.65 mL in 1 DRUMLIQUID208197.652
78517-801-67Pyroxy Liquid-80B25362259 mL in 1 TANKLIQUID253622592
78517-801-91Pyroxy Liquid-80B1000 mL in 1 BOTTLELIQUID10002
78517-801-92Pyroxy Liquid-80B250 mL in 1 BOTTLELIQUID2502
78517-801-95Pyroxy Liquid-80B18927.05 mL in 1 PAILLIQUID18927.052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78517-801PYROXY LIQUID-80B (ALCOHOL 80%) LIQUID [PYROCK CHEMICAL]2Legacy NDC, 8 package rows20220131_a7d0c766-c9d8-3457-e053-2995a90ab480.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
d6d2cf6d-08ad-ded1-e053-2995a90ab1eca7d0c766-c9d8-3457-e053-2995a90ab4802022-01-30WarningsExact identifier
spl id: d6d2cf6d-08ad-ded1-e053-2995a90ab1ec
spl set id: a7d0c766-c9d8-3457-e053-2995a90ab480

Reported adverse events (FAERS/openFDA)#

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