70% Alcohol GEL Hand Sanitizer

Gel Hand Sanitizer by

Drug Labeling and Warnings

Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ProEdge, Inc., Marquis Extraction Technology LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GEL HAND SANITIZER- gel hand sanitizer gel 
ProEdge, Inc.

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.

----------

70% Alcohol GEL Hand Sanitizer

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
• in eyes

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

• 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

acrylates copolymer, alpha-tocopherol acetate, denatonium benzoate, fragrance, glycerin, isopropyl myristate, propylene glycol, triisopropanolamine, water

Package Label - Principal Display Panel

236 mL NDC: 74163-125-08

GEL HAND SANITIZER 
gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74163-125(NDC: 76585-009)
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
GLYCERIN (UNII: PDC6A3C0OX)	5 mL  in 100 mL
METHACRYLIC ACID (UNII: 1CS02G8656)	5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74163-125-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020	03/31/2022
2	NDC: 74163-125-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020	03/31/2022
3	NDC: 74163-125-01	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/05/2020	03/31/2022

Labeler - ProEdge, Inc. (945239291)

Registrant - ProEdge, Inc. (945239291)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis Extraction Technology LLC		117496233	manufacture(74163-125)

Establishment
Name	Address	ID/FEI	Business Operations
ProEdge, Inc.		945239291	repack(74163-125)

Revised: 3/2022

Document Id: db76c9e0-db91-2c45-e053-2995a90a8665

34390-5

Set id: afed1ae9-735c-7df3-e053-2995a90aea0a

Version: 3

Effective Time: 20220330