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.
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.
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
This is a hand sanitizer manufactured according to the
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
Alcohol 80% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame
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.
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.
glycerin, hydrogen peroxide, purified water USP
Indications and Usage
Back label image description corrected. Image was deleted and re-uploaded because it was undefined.
Inserted image above content wording. Deleted and re-uploaded
Dosage and Administration
Pressed enter to get rid of a bullet point so I could insert image
Indications and Usage 4/2020 - added new packaging label for 750ml 80% alcohol
Dosage and administration 4/2020 - added new packaging label for 750ml 80% alcohol
375 ml NDC: 74357-0001-1
750 ml NDC: 74357-0002-2
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74357-0001-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a495-a426-e053-dadaa90af4c2 | a23a15c4-1b08-e7ac-e053-2995a90ad31b |
| 74357-0002-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a495-a426-e053-dadaa90af4c2 | a23a15c4-1b08-e7ac-e053-2995a90ad31b |
| 74357-0002-2 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a495-a426-e053-dadaa90af4c2 | a23a15c4-1b08-e7ac-e053-2995a90ad31b |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74357-0001-1 | Hand Sanitizer | 750 mL in 1 BOTTLE, GLASS | LIQUID | 750 | 2 | |
| 74357-0002-1 | Hand Sanitizer | 750 mL in 1 BOTTLE, GLASS | LIQUID | 750 | 2 | |
| 74357-0002-2 | Hand Sanitizer | 750 mL in 1 BOTTLE, GLASS | LIQUID | 750 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 74357-0001 | HAND SANITIZER (DR MONTYS GERM BUSTER) LIQUID HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [MONTEZUMA WINERY LLC] | 2 | Legacy NDC, 1 package rows | 20200428_a23a15c4-1b08-e7ac-e053-2995a90ad31b.zip |
| 74357-0002 | HAND SANITIZER (DR MONTYS GERM BUSTER) LIQUID HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [MONTEZUMA WINERY LLC] | 2 | Legacy NDC, 2 package rows | 20200428_a23a15c4-1b08-e7ac-e053-2995a90ad31b.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 74357-0001 | 74357-0001-1 |
| 74357-0002 | 74357-0002-1, 74357-0002-2 |
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 |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a3928c7b-85dc-3d1e-e053-2a95a90a425c | a23a15c4-1b08-e7ac-e053-2995a90ad31b | 2020-04-18 | Warnings | a3928c7b-85dc-3d1e-e053-2a95a90a425c a23a15c4-1b08-e7ac-e053-2995a90ad31b |
Adverse event summaries are temporarily unavailable. Other product information remains available.