RUBZAN- isopropyl 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 ingredient[s]

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Use[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, polyacrylic crosspolymer, hydrogen peroxide, purified water USP.

RUBZAN +

Contains 70% v/v isopropyl alcohol
Hygienic Hand Rub
Kills germs and bacteria
Fragrance Free

Leaves hands feeling soft while killing 99.99% of germs

PRIME ECO GROUP, INC.

WHARTON TX 77488

WWW.PRIMEECOGROUP.COM

MADE IN USA

Packaging

RUBZAN
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75549-770
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 L in 100 L

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75549-770-12	0.354 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2020	07/31/2022
2	NDC:75549-770-16	0.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020	07/31/2022
3	NDC:75549-770-01	3.785 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2020	07/31/2022
4	NDC:75549-770-05	18.927 L in 1 PAIL; Type 0: Not a Combination Product	04/27/2020	07/31/2022
5	NDC:75549-770-55	208.198 L in 1 DRUM; Type 0: Not a Combination Product	04/27/2020	07/31/2022
6	NDC:75549-770-75	1040.99 L in 1 CONTAINER; Type 0: Not a Combination Product	04/27/2020	07/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020	07/31/2022

Labeler - Prime Eco Group, Inc. (097411727)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Eco Group, Inc.		097411727	manufacture(75549-770)

Revised: 8/2022

Document Id: 3d18abce-f61a-479a-bb97-92500b248e8d

Set id: 6a7b4e1e-ea50-4c9c-9c27-b2d7cc4af7f7

Version: 3

Effective Time: 20220819

Prime Eco Group, Inc.