Pyroxy Gel-70 Base Poly Clear

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 Gel-70 Base Poly Clear
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

The hand sanitizer is manufactured in response to the COVID-19 pandemic

  1. Alcohol (ethanol) (70%, 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 (2.01% v/v).
  3. Carbomber (1.33% v/v).
  4. Deionized or reverse osmosis water

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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, purified water, carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front 18927.05 mL NDC: 78517-711-95Front 18927.05 mL NDC: 78517-711-95

Back 18927.05 mL NDC: 78517-711-95Back 18927.05 mL NDC: 78517-711-95

Front 1249185.9 mL NDC: 78517-711-33Front 1249185.9 mL NDC: 78517-711-33Back 1249185.9 mL NDC: 78517-711-33Back 1249185.9 mL NDC: 78517-711-33

Front 1040988.2 mL NDC: 78517-711-27Front 1040988.2 mL NDC: 78517-711-27Back 1040988.2 mL NDC: 78517-711-27Back 1040988.2 mL NDC: 78517-711-27

Front 208197.65 mL NDC: 78517-711-55Front 208197.65 mL NDC: 78517-711-55Back ​208197.65 mL NDC: 78517-711-55Back ​208197.65 mL NDC: 78517-711-55

Front 25362259 mL NDC: 78517-711-67Front 25362259 mL NDC: 78517-711-67Back 25362259 mL NDC: 78517-711-67Back 25362259 mL NDC: 78517-711-67

Front 3785.41 mL NDC: 78517-711-01Front 3785.41 mL NDC: 78517-711-01Back 3785.41 mL NDC: 78517-711-01Back 3785.41 mL NDC: 78517-711-01

Front 250 mL NDC: 78517-711-92Front 250 mL NDC: 78517-711-92Back ​250 mL NDC: 78517-711-92Back ​250 mL NDC: 78517-711-92

Front 1000 ml NDC: 78517-711-91Front 1000 ml NDC: 78517-711-91Back ​1000 ml NDC: 78517-711-91Back ​1000 ml NDC: 78517-711-91

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78517-711-012024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-272024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-332024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-552024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-672024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-912024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-922024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-952024-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-012022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-272022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-332022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-552022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-672022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-912022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-922022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-952022-01-30C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-012022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-272022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-332022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-552022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-672022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-912022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-922022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer
78517-711-952022-01-28C16284748780-1d6a99b39-46c4-a426-e053-dadaa90af4c2Pyrock Gel 70B - New Polymer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78517-711-01Pyroxy Gel-70 Base Poly Clear3785.41 mL in 1 BOTTLE, PUMPGEL3785.412
78517-711-27Pyroxy Gel-70 Base Poly Clear1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL1040988.22
78517-711-33Pyroxy Gel-70 Base Poly Clear1249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL1249185.92
78517-711-55Pyroxy Gel-70 Base Poly Clear208197.65 mL in 1 DRUMGEL208197.652
78517-711-67Pyroxy Gel-70 Base Poly Clear25362259 mL in 1 TANKGEL253622592
78517-711-91Pyroxy Gel-70 Base Poly Clear1000 mL in 1 BOTTLEGEL10002
78517-711-92Pyroxy Gel-70 Base Poly Clear250 mL in 1 BOTTLEGEL2502
78517-711-95Pyroxy Gel-70 Base Poly Clear18927.05 mL in 1 PAILGEL18927.052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78517-711PYROXY GEL-70 BASE POLY CLEAR (70% GEL HAND SANITIZER - BASE POLY CLEAR) GEL [PYROCK CHEMICAL]2Legacy NDC, 8 package rows20220131_ae667bbf-9d8d-9fd6-e053-2a95a90a459e.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
d6d2bbc0-194b-a853-e053-2995a90a8eaeae667bbf-9d8d-9fd6-e053-2a95a90a459e2022-01-30WarningsExact identifier
spl id: d6d2bbc0-194b-a853-e053-2995a90a8eae
spl set id: ae667bbf-9d8d-9fd6-e053-2a95a90a459e

Reported adverse events (FAERS/openFDA)#

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