OTC - ACTIVE INGREDIENT SECTION
Alcohol 80 % v/v
Hand Sanitizer
- Manufacturer
- Silverback Spirits LLC
- Effective date
- 2020-04-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:08:29
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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 40 C (104F)
INACTIVE INGREDIENT SECTION
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Hand Sanitizer
3785.41mL NDC: 74554-100-02
Hand Sanitizer
236.58mL NDC: 74554-100-03
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 |
|---|---|---|---|---|---|
| 74554-100-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a80-a426-e053-dadaa90af4c2 | Hand sanitizer |
| 74554-100-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a80-a426-e053-dadaa90af4c2 | Hand sanitizer |
| 74554-100-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a80-a426-e053-dadaa90af4c2 | Hand sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74554-100-01 | Hand Sanitizer | 118 mL in 1 BOTTLE | LIQUID | 118 | 2 | |
| 74554-100-02 | Hand Sanitizer | 3785.41 mL in 1 BOTTLE | LIQUID | 3785.41 | 2 | |
| 74554-100-03 | Hand Sanitizer | 236.58 mL in 1 BOTTLE | LIQUID | 236.58 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74554-100 | 74554-100-01, 74554-100-02, 74554-100-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| a45d8e7d-97e0-9ac1-e053-2995a90a6f49 | a1f0c4a8-dbc7-3890-e053-2a95a90a7ff2 | 2020-04-28 | Warnings | a45d8e7d-97e0-9ac1-e053-2995a90a6f49 a1f0c4a8-dbc7-3890-e053-2a95a90a7ff2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.