Hand Sanitizer
- Manufacturer
- Black Irish Products, LLC. | Redi-2-PaQ Home Products, LLC. | Black Irish Products
- Effective date
- 2021-03-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:40:42
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Ethyl Alcohol 75% v/v Purpose: Antiseptic
INDICATIONS & USAGE SECTION
OTC - WHEN USING SECTION
Keep out of eyes, ears, and mouth. In case of contact with the eyes, rinse eyes thoroughly with water.
OTC - WHEN USING SECTION
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise with children under 6 years of age when using this product to avoid swallowing.
WARNINGS SECTION
OTC - DO NOT USE SECTION
- on chilren less then 2 months of age
- on open skin wounds
OTC - STOP USE SECTION
if irritation or rash occurs. These may be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
Apply dime size amount to hands and
OTC - PURPOSE SECTION
Hand sanitizer to help reuce bacteria that potentially can cause disease. For use when soap and water are not available.
OTC - QUESTIONS SECTION
Visit penta5usa.com or call toll free 1-800-511-5609
OTHER SAFETY INFORMATION
- Store between 15-30 Degrees C (59-86 F)
- Avoid freexing and excessive heat about 40 C (104 F)
INACTIVE INGREDIENT SECTION
Water, Carbopol Aqua SF1, Hydrogen Peroxide 3%, Glycerol, Fragrance, AMP PC2000
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
59 mL NDC 80589-001-02
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
3785 mL, NDC 80589-001-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
60 mL NDC 80589-001-04
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
133 mL NDC 80589-001-05
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80589-001-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ba6-0266-e053-dadaa90a7c1a | be5d0c55-519d-4836-e053-2995a90a6edb |
| 80589-001-02 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ba6-0266-e053-dadaa90a7c1a | be5d0c55-519d-4836-e053-2995a90a6edb |
| 80589-001-03 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ba6-0266-e053-dadaa90a7c1a | be5d0c55-519d-4836-e053-2995a90a6edb |
| 80589-001-04 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ba6-0266-e053-dadaa90a7c1a | be5d0c55-519d-4836-e053-2995a90a6edb |
| 80589-001-05 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ba6-0266-e053-dadaa90a7c1a | be5d0c55-519d-4836-e053-2995a90a6edb |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80589-001-01 | Hand Sanitizer | 236 mL in 1 BOTTLE, PUMP | GEL | 236 | 1 | |
| 80589-001-02 | Hand Sanitizer | 59 mL in 1 BOTTLE | GEL | 59 | 1 | |
| 80589-001-03 | Hand Sanitizer | 3785 mL in 1 BOTTLE, PUMP | GEL | 3785 | 1 | |
| 80589-001-04 | Hand Sanitizer | 59 mL in 1 BOTTLE | GEL | 59 | 1 | |
| 80589-001-05 | Hand Sanitizer | 133 mL in 1 POUCH | GEL | 133 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- Ethyl Alcohol
- WATER
- CARBOMER COPOLYMER TYPE A
- HYDROGEN PEROXIDE
- GLYCERIN
- FRAGRANCE LEMON ORC2001060
- .ALPHA.,.BETA.-METHYLENE ADENOSINE 5'-DIPHOSPHATE
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80589-001 | 80589-001-01, 80589-001-02, 80589-001-03, 80589-001-04, 80589-001-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| CARBOMER COPOLYMER TYPE A | 71DD5V995L | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FRAGRANCE LEMON ORC2001060 | K1725A7G95 | IACT |
| .ALPHA.,.BETA.-METHYLENE ADENOSINE 5'-DIPHOSPHATE | 0T2A5439OE | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
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 |
|---|---|---|---|---|---|---|
| be5d0b4e-44a1-852b-e053-2a95a90a49bb | be5d0c55-519d-4836-e053-2995a90a6edb | 2021-03-25 | Warnings | be5d0b4e-44a1-852b-e053-2a95a90a49bb be5d0c55-519d-4836-e053-2995a90a6edb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.