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.
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.
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) Avoid Direct Sunlight, store in an opaque bottle. Keep sealed when not in use.
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.
HOCl solutions are already included in the WHO list of coronavirus-effective biocides, and in the US EPA ‘N’ list of disinfecting agents able to control emerging pathogens like SARS-CoV-2. 37,126 More than ten branded aqueous HOCl formulations have been cleared by the US FDA for topical use in wound management over the last decade. A Class III medical product approval for HOCl has been granted in the EU, and the Japanese Ministry of Health has approved use of HOCl for topical medical applications. The US FDA has approved HOCl for high level disinfection and sterilization of medical instruments, including those for use at critical (i.e., sterile) sites
HOCL 385ppm Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
None
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.
Purified water USP
3785 mL NDC: 77368-385-01
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77368-385-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| 77368-385-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| 77368-385-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| 77368-385-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| 77368-385-55 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| 77368-385-75 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0136-111a-e063-dadaa90a10e2 | NuRinse Hand Sanitizer |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77368-385-05 | NuRinse | 18927 mL in 1 BOTTLE | LIQUID | 18927 | 6 | |
| 77368-385-08 | NuRinse | 237 mL in 1 BOTTLE | LIQUID | 237 | 6 | |
| 77368-385-12 | NuRinse | 355 mL in 1 BOTTLE | LIQUID | 355 | 6 | |
| 77368-385-16 | NuRinse | 474 mL in 1 BOTTLE | LIQUID | 474 | 6 | |
| 77368-385-55 | NuRinse | 208198 mL in 1 BOTTLE | LIQUID | 208198 | 6 | |
| 77368-385-75 | NuRinse | 10409875 mL in 1 BOTTLE | LIQUID | 10409875 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 77368-385 | 77368-385-05, 77368-385-55, 77368-385-75, 77368-385-08, 77368-385-12, 77368-385-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPOCHLOROUS ACID | 712K4CDC10 | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| f074239f-688b-e484-e053-2a95a90a46b5 | d311852d-e33a-0f74-e053-2995a90a3863 | 2022-12-22 | Warnings | f074239f-688b-e484-e053-2a95a90a46b5 d311852d-e33a-0f74-e053-2995a90a3863 |
Adverse event summaries are temporarily unavailable. Other product information remains available.