Indications and uses
Antiseptic hand rub and sanitizing gel to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
RUBZAN Hand Gel Sanitizer
- Manufacturer
- Prime Eco Group, Inc.
- Effective date
- 2020-06-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:26:26
Label at a glance#
ProductRubzan
Active ingredientALCOHOL
Label structure9 sections
Dosage and administration
• 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.
Storage and handling
• Store between 59-86°F (15-30°C) • Avoid freezing and excessive heat above 104°F (40°C)
Contacts and useful links#
Websitewww.primecogroup.com
www.primecogroup.com
www.primecogroup.comLabel contents#
Full prescribing information#
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
SPL UNCLASSIFIED SECTION
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75549-470-01 | 2022-08-22 | C162847 | 48780-1 | d6a99b39-c328-a426-e053-dadaa90af4c2 | RUBZAN Hand Gel Sanitizer |
| 75549-470-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c328-a426-e053-dadaa90af4c2 | RUBZAN Hand Gel Sanitizer |
Products#
Every source-derived product name is available through these pages.
- Rubzan
- Ethyl Alcohol
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
- POLYACRYLIC ACID (8000 MW)
- 2-BUTYLAMINOETHANOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75549-470 | 75549-470-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| 2-BUTYLAMINOETHANOL | 3IBO99KPV6 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9f132d38-ce22-44ca-8d29-9755bfbc2e4f | 05de2a22-67aa-4d80-97a8-94af1a16b4cf | 2022-08-19 | Warnings | 05de2a22-67aa-4d80-97a8-94af1a16b4cf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.