PYROXY GEL-70 BASE- 70% gel hand sanitizer - base gel 
Pyrock Chemical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Pyroxy Gel-70 Base

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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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.

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.

Directions

Other information

Inactive ingredients

glycerin, purified water, carbomer

Package Label - Principal Display Panel

18927.05 mL NDC: 78517-701-95

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

1249185.9 mL NDC: 78517-701-33

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

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

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

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

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

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

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

PYROXY GEL-70 BASE 
70% gel hand sanitizer - base gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78517-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) 1.34 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.06 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 26.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78517-701-6725362259 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
2NDC:78517-701-331249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:78517-701-271040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
4NDC:78517-701-55208197.65 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
5NDC:78517-701-013785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
6NDC:78517-701-911000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:78517-701-92250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:78517-701-9518927.05 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Pyrock Chemical (117537129)
Establishment
NameAddressID/FEIBusiness Operations
Reflow Supply Chain Solutions LLC117537129manufacture(78517-701)

Revised: 1/2022
Document Id: d6d2c5bb-54db-1782-e053-2995a90affbc
Set id: a6d4ddc9-18b3-43e4-e053-2a95a90a70b3
Version: 3
Effective Time: 20220130
 
Pyrock Chemical