Indications and uses
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Premium Gel Hand Sanitizer
- Manufacturer
- Premium Printing Inc.
- Effective date
- 2020-06-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:19:39
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
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
Ethyl Alcohol 70%
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
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 children.
If swallowed, get medical help or contact a Poison Control Center immediately.
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
Carbopol, Glycerin, Triethanolamine
Gel Hand Sanitizer
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78635-100-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dcb4-a426-e053-dadaa90af4c2 | Premium Gel Hand Sanitizer |
| 78635-100-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dcb4-a426-e053-dadaa90af4c2 | Premium Gel Hand Sanitizer |
| 78635-100-33 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dcb4-a426-e053-dadaa90af4c2 | Premium Gel Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78635-100-04 | Hand Sanitizer | 4000 mL in 1 BOTTLE | GEL | 4000 | 1 | |
| 78635-100-08 | Hand Sanitizer | 250 mL in 1 BOTTLE | GEL | 250 | 1 | |
| 78635-100-33 | Hand Sanitizer | 1000 mL in 1 BOTTLE | GEL | 1000 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- Ethyl Alcohol 70%
- POLYACRYLIC ACID (250000 MW)
- ALCOHOL
- TRIETHANOLAMINE ISOSTEARATE
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78635-100 | 78635-100-08, 78635-100-33, 78635-100-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYACRYLIC ACID (250000 MW) | 9G2MAD7J6W | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| TRIETHANOLAMINE ISOSTEARATE | T8OTU5ECY5 | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| a8fe8dd8-a2b1-9002-e053-2995a90a51aa | a8fe89e5-0240-7b99-e053-2a95a90a2dc4 | 2020-06-26 | Warnings | a8fe8dd8-a2b1-9002-e053-2995a90a51aa a8fe89e5-0240-7b99-e053-2a95a90a2dc4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.