Dosage and administration
• Place enough product on hands to cover all surfaces. Rub hands together continuously until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.
Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution
- Manufacturer
- Pegasus Biotechnology LLC.
- Effective date
- 2020-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:31:25
Label at a glance#
ProductAlcohol Antiseptic Hand Sanitizer Non-Sterile Solution
Active ingredientALCOHOL
Label structure11 sections
Label contents#
Full prescribing information#
Active ingredient[s]
Alcohol 80% v/v
Purpose
Antiseptic
Use[s]
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
- in 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 chilren.
If swallowed, get medical help or contact a Poison Control Center
Directions
• Place enough product on hands to cover all surfaces. Rub hands together continuously 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
Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1
Package Labeling:50 ml
Package Labeling:100 ml
Package Labeling:250 ml
Package Labeling:500 ml
Package Labeling: 1000
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80095-000-00 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aedf-a426-e053-dadaa90af4c2 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
| 80095-000-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aedf-a426-e053-dadaa90af4c2 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
| 80095-000-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aedf-a426-e053-dadaa90af4c2 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
| 80095-000-25 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aedf-a426-e053-dadaa90af4c2 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
| 80095-000-50 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aedf-a426-e053-dadaa90af4c2 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80095-000-00 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution | 1000 mL in 1 BOTTLE | GEL | 1000 | 1 | |
| 80095-000-05 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution | 50 mL in 1 BOTTLE | GEL | 50 | 1 | |
| 80095-000-10 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution | 100 mL in 1 BOTTLE | GEL | 100 | 1 | |
| 80095-000-25 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution | 250 mL in 1 BOTTLE | GEL | 250 | 1 | |
| 80095-000-50 | Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution | 500 mL in 1 BOTTLE | GEL | 500 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution
- ALCOHOL
- ALOE VERA LEAF
- .ALPHA.-TOCOPHEROL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- TEA LEAF
- WATER
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80095-000 | 80095-000-05, 80095-000-10, 80095-000-25, 80095-000-50, 80095-000-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| TEA LEAF | GH42T47V24 | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 |
|---|---|---|---|---|---|---|
| ae41e260-623f-f4ea-e053-2995a90a6e6b | ae41da2e-8d69-b5be-e053-2a95a90a8e8c | 2020-09-01 | Warnings | ae41e260-623f-f4ea-e053-2995a90a6e6b ae41da2e-8d69-b5be-e053-2a95a90a8e8c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.