FDA.reportPublic FDA data

Pyroxy Gel-70 Base

Manufacturer
Pyrock Chemical | Reflow Supply Chain Solutions LLC
Effective date
2022-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:47

Label at a glance#

ProductPyroxy Gel-70 Base
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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18927.05 mL NDC: 78517-701-95

NDC: 78517-701-95 - FrontNDC: 78517-701-95 - FrontNDC: 78517-701-95 - BackNDC: 78517-701-95 - Back

1249185.9 mL NDC: 78517-701-33

NDC: 78517-701-33 - FrontNDC: 78517-701-33 - FrontNDC: 78517-701-33 - BackNDC: 78517-701-33 - Back1040988.2 mL NDC: 78517-701-27

NDC: 78517-701-27 - FrontNDC: 78517-701-27 - FrontNDC: 78517-701-27 - BackNDC: 78517-701-27 - Back208197.65 mL NDC: 78517-701-55

NDC: 78517-701-55 - FrontNDC: 78517-701-55 - FrontNDC: 78517-701-55 - BackNDC: 78517-701-55 - Back25362259 mL NDC: 78517-701-67

NDC: 78517-701-67 - FrontNDC: 78517-701-67 - FrontNDC: 78517-701-67 - BackNDC: 78517-701-67 - Back3785.41 mL NDC: 78517-701-01

NDC: 78517-701-01 - FrontNDC: 78517-701-01 - FrontNDC: 78517-701-01 - BackNDC: 78517-701-01 - Back250 mL NDC: 78517-701-92

NDC: 78517-701-92 - FrontNDC: 78517-701-92 - FrontNDC: 78517-701-92 - BackNDC: 78517-701-92 - Back1000 ml NDC: 78517-701-91

NDC: 78517-701-91 - FrontNDC: 78517-701-91 - FrontNDC: 78517-701-91 - BackNDC: 78517-701-91 - Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78517-701-012024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-272024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-332024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-552024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-672024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-912024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-922024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-952024-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-012022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-272022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-332022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-552022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-672022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-912022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-922022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-952022-01-30C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-012022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-272022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-332022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-552022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-672022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-912022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-922022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base
78517-701-952022-01-28C16284748780-1d6a99b39-f4f4-a426-e053-dadaa90af4c2Pyroxy Gel-70 Base

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78517-701-01Pyroxy Gel-70 Base3785.41 mL in 1 BOTTLE, PUMPGEL3785.413
78517-701-27Pyroxy Gel-70 Base1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL1040988.23
78517-701-33Pyroxy Gel-70 Base1249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL1249185.93
78517-701-55Pyroxy Gel-70 Base208197.65 mL in 1 DRUMGEL208197.653
78517-701-67Pyroxy Gel-70 Base25362259 mL in 1 TANKGEL253622593
78517-701-91Pyroxy Gel-70 Base1000 mL in 1 BOTTLEGEL10003
78517-701-92Pyroxy Gel-70 Base250 mL in 1 BOTTLEGEL2503
78517-701-95Pyroxy Gel-70 Base18927.05 mL in 1 PAILGEL18927.053

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78517-701PYROXY GEL-70 BASE (70% GEL HAND SANITIZER - BASE) GEL [PYROCK CHEMICAL]3Legacy NDC, 8 package rows20220131_a6d4ddc9-18b3-43e4-e053-2a95a90a70b3.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78517-70178517-701-67, 78517-701-33, 78517-701-27, 78517-701-55, 78517-701-01, 78517-701-91, 78517-701-92, 78517-701-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d6d2c5bb-54db-1782-e053-2995a90affbca6d4ddc9-18b3-43e4-e053-2a95a90a70b32022-01-30WarningsExact identifier
spl id: d6d2c5bb-54db-1782-e053-2995a90affbc
spl set id: a6d4ddc9-18b3-43e4-e053-2a95a90a70b3

Reported adverse events (FAERS/openFDA)#

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