Storage and handling
Store between 15-30C (59-86F) Avoiding freezing and excessive heat above 40C (104F)
Store between 15-30C (59-86F) Avoiding freezing and excessive heat above 40C (104F)
This sanitizer is manufactured using only the following United States Pharmacopoei (USP) grade ingredients in the preparation of the product (percentage in the final product formulation) consistent with World Health Organization (WHO):
Belzankonium Chloride (0.2% volume/volume (v/v)) in an aqueous solution).
Alcohol (isopropylic alcohol) (10% v/v)
Sterile distilled water or boiled cold water.
This firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Benzalkonium Chloride. Purpose: Antiseptic
Antiseptic, Hands, Surface and Cloths Sanitizer.
Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water ar not available.
For external use only.
in children less than 2 months of age
on open skin wounds
When using this product keep out eyes, ears, 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 conditions.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Place enough product on hands or surfaces to cover all. Rub hands together untill dry.
Supervise children under 6 years of age when using this products to avoid swallowing.
Store between 15-30C (59-86F)
Avoiding freezing and excessive heat above 40C (104F)
Isopropylic Alcohol, purified water USP.
250 ml NDC: 77308-003-01
1 L NDC: 77308-003-03
4 L NDC: 77308-003-04
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77308-003-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5c35-a426-e053-dadaa90af4c2 | a92dae8a-6e86-6530-e053-2995a90a444a |
| 77308-003-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5c35-a426-e053-dadaa90af4c2 | a92dae8a-6e86-6530-e053-2995a90a444a |
| 77308-003-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5c35-a426-e053-dadaa90af4c2 | a92dae8a-6e86-6530-e053-2995a90a444a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77308-003-01 | SANITIZERACE-SA001 | 0.25 L in 1 BOTTLE | LIQUID | 0.25 | 1 | |
| 77308-003-03 | SANITIZERACE-SA001 | 1 L in 1 BOTTLE | LIQUID | 1 | 1 | |
| 77308-003-04 | SANITIZERACE-SA001 | 4 L in 1 BOTTLE, PLASTIC | LIQUID | 4 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 77308-003 | 77308-003-01, 77308-003-03, 77308-003-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | 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 |
|---|---|---|---|---|---|---|
| a92dae8a-6e87-6530-e053-2995a90a444a | a92dae8a-6e86-6530-e053-2995a90a444a | 2020-06-28 | Warnings | a92dae8a-6e87-6530-e053-2995a90a444a a92dae8a-6e86-6530-e053-2995a90a444a |
Adverse event summaries are temporarily unavailable. Other product information remains available.