RUBZAN- isopropyl alcohol gel

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]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

RUBZAN 
isopropyl alcohol gel

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

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

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

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

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

Labeler - Prime Eco Group, Inc. (097411727)

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