RUBZAN Hand Gel Sanitizer

Rubzan by

Drug Labeling and Warnings

Rubzan by is a Otc medication manufactured, distributed, or labeled by Prime Eco Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUBZAN- ethyl alcohol gel 
Prime Eco Group, 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.

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RUBZAN Hand Gel Sanitizer

Drug Facts

Active ingredients[s]

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses[s]

Antiseptic hand rub and sanitizing gel 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

on children less than 2 months of age

on open skin wounds

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 small 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 59-86°F (15-30°C)

Avoid freezing and excessive heat above 104°F (40°C)

Inactive ingredients

Glycerin, Hydrogen peroxide, Deionized water, Polyacrylic Acid, 2-butylaminoethanol, Fragrance

Keep your surroundings sanitized by killing 99% of bacteria, and germs

Hygienic Hand Rub

Kills viruses, germs, and bacteria

Fragranced

Prime Eco Group, Inc.   Wharton, TX      www.primecogroup.com

MADE IN USA

Packaging

RUBZAN 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75549-470
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
2-BUTYLAMINOETHANOL (UNII: 3IBO99KPV6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75549-470-01	3.785 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020	07/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020	07/31/2022

Labeler - Prime Eco Group, Inc. (097411727)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Eco Group, Inc.		097411727	manufacture(75549-470)

Revised: 8/2022

Document Id: 9f132d38-ce22-44ca-8d29-9755bfbc2e4f

34390-5

Set id: 05de2a22-67aa-4d80-97a8-94af1a16b4cf

Version: 2

Effective Time: 20220819