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.
Hand Gel Sanitizer
- Manufacturer
- Allied Pressroom Products
- Effective date
- 2020-06-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:18:37
Label at a glance#
ProductHand Gel Sanitizer
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is an ethanol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.
It is manufactured by gelling a 70 % ethanol solution with the the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin (1.00 % v/v)..
- Polypropylene Glycol (1.2 % v/v)..
- Acrylate Polymer (0.3% v/v).
- Sterile distilled water or boiled cold water.
No other materials are used.
Active Ingredient(s)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
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
OTC - WHEN USING SECTION
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 right away.
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.
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
Water, Polypropylene Glycol, glycerin, Acrylate polymer.
Package Label - Principal Display Panel
3785 ml NDC 78851-333-05
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78851-333-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f655-a426-e053-dadaa90af4c2 | Hand Gel Ethyl Alcohol Sanitizer |
| 78851-333-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f655-a426-e053-dadaa90af4c2 | Hand Gel Ethyl Alcohol Sanitizer |
| 78851-333-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f655-a426-e053-dadaa90af4c2 | Hand Gel Ethyl Alcohol Sanitizer |
| 78851-333-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f655-a426-e053-dadaa90af4c2 | Hand Gel Ethyl Alcohol Sanitizer |
| 78851-333-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f655-a426-e053-dadaa90af4c2 | Hand Gel Ethyl Alcohol Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78851-333-01 | Hand Gel Sanitizer | 105 mL in 1 BOTTLE, PLASTIC | GEL | 105 | 1 | |
| 78851-333-02 | Hand Gel Sanitizer | 120 mL in 1 BOTTLE, PLASTIC | GEL | 120 | 1 | |
| 78851-333-03 | Hand Gel Sanitizer | 240 mL in 1 BOTTLE, PLASTIC | GEL | 240 | 1 | |
| 78851-333-04 | Hand Gel Sanitizer | 946 mL in 1 BOTTLE, PLASTIC | GEL | 946 | 1 | |
| 78851-333-05 | Hand Gel Sanitizer | 3785 mL in 1 BOTTLE, PUMP | GEL | 3785 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Gel Sanitizer
- ALCOHOL
- POLYETHYLENE GLYCOL 1000
- ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE)
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78851-333 | 78851-333-01, 78851-333-02, 78851-333-03, 78851-333-04, 78851-333-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) | PI80E777XB | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| a87177ed-8f52-79fe-e053-2995a90a33f1 | a87177ed-8f61-79fe-e053-2995a90a33f1 | 2020-06-19 | Warnings | a87177ed-8f52-79fe-e053-2995a90a33f1 a87177ed-8f61-79fe-e053-2995a90a33f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.