Indications and uses
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Guardex Hand Sanitizer Antiseptic Gel
- Manufacturer
- Guardex Labs, Inc.
- Effective date
- 2020-09-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:26:49
Label at a glance#
ProductGuardex Hand Sanitizer Antiseptic Gel
Active ingredientISOPROPYL ALCOHOL
Label structure12 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.
Label contents#
Full prescribing information#
Active Ingredient
Isopropyl Alcohol 75%
Purpose
Antiseptic
Uses
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
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 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
glycerin, hydrogen peroxide, Triethanolamine, carbomer, purified water USP
Guardex Hand Sanitizer gel
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80307-001-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-2031-fd44-e053-dadaa90aa01b | Guardex Hand Sanitizer Antiseptic Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80307-001-01 | Guardex Hand Sanitizer Antiseptic Gel | 3785 mL in 1 BOTTLE | GEL | 3785 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Guardex Hand Sanitizer Antiseptic Gel
- Isopropyl Alcohol 75%
- TRIETHANOLAMINE TRISTEARATE
- HYDROGEN PEROXIDE
- GLYCERIN
- ISOPROPYL ALCOHOL
- WATER
- (3-BROMOPROPYL)BENZENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80307-001 | 80307-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIETHANOLAMINE TRISTEARATE | HOM72YRP1F | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| (3-BROMOPROPYL)BENZENE | 6VX623QN9V | 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 |
|---|---|---|---|---|---|---|
| ae6c65d1-0597-71df-e053-2995a90ad77f | ae6c65d1-0598-71df-e053-2995a90ad77f | 2020-09-03 | Warnings | ae6c65d1-0597-71df-e053-2995a90ad77f ae6c65d1-0598-71df-e053-2995a90ad77f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.