OTC - ACTIVE INGREDIENT SECTION
Ethanol 80%
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
- Manufacturer
- Baltimore Whiskey Company LLC
- Effective date
- 2020-04-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:06:07
Label at a glance#
ProductBaltimore Spirits Co Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Antiseptic
INDICATIONS & USAGE SECTION
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
WARNINGS SECTION
For external use only. Flammable. Keep away from heat or flame
OTC - DO NOT USE SECTION
• in children less than 2 months of age
• on open skin wounds
OTC - STOP USE SECTION
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 children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
Inactive ingredients denatonium benzoate, glycerin, hydrogen peroxide, purified water USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73865-000-00 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d61d-a426-e053-dadaa90af4c2 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73865-000-00 | Baltimore Spirits Co Hand Sanitizer | 3785 mL in 1 BOTTLE, PUMP | LIQUID | 3785 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Baltimore Spirits Co Hand Sanitizer
- Alcohol
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
- DENATONIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73865-000 | 73865-000-00 |
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 |
| DENATONIUM BENZOATE | 4YK5Z54AT2 | 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 |
|---|---|---|---|---|---|---|
| a335c759-4781-36bd-e053-2995a90ab735 | a14fd022-3165-0b47-e053-2995a90a11e4 | 2020-04-13 | Warnings | a335c759-4781-36bd-e053-2995a90ab735 a14fd022-3165-0b47-e053-2995a90a11e4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.