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

Pyroxy Gel-70 Base by

Drug Labeling and Warnings

Pyroxy Gel-70 Base by is a Otc medication manufactured, distributed, or labeled by Pyrock Chemical, Reflow Supply Chain Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, purified water, carbomer

Package Label - Principal Display Panel

18927.05 mL NDC: 78517-701-95

1249185.9 mL NDC: 78517-701-33

1040988.2 mL NDC: 78517-701-27

208197.65 mL NDC: 78517-701-55

25362259 mL NDC: 78517-701-67

3785.41 mL NDC: 78517-701-01

250 mL NDC: 78517-701-92

1000 ml NDC: 78517-701-91

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78517-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78517-701-67	25362259 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78517-701-33	1249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78517-701-27	1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78517-701-55	208197.65 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78517-701-01	3785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
6	NDC: 78517-701-91	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 78517-701-92	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 78517-701-95	18927.05 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Pyrock Chemical (117537129)

Establishment
Name	Address	ID/FEI	Business Operations
Reflow Supply Chain Solutions LLC		117537129	manufacture(78517-701)