Indications and uses
HAND SANITIZER TO DECREASE BACTERIA ON THE SKIN RECOMMENDED FOR REPEATED USE
Mi
- Manufacturer
- Infinity Manufacturing of America, LLC | Bama-Bio Tech Corporation | Infinity Manufacturing of America
- Effective date
- 2021-02-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:39:54
Label at a glance#
ProductMi
Active ingredientBENZALKONIUM CHLORIDE
Label structure18 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 hand sanitizer manufactured according to OTC Monograph part 333a
Purpose
Antiseptic, Hand Sanitizer
WARNINGS SECTION
• FOR EXTERNAL USE ONLY
• DO NOT USE ON CHILDREN UNDER 2 MONTHS OF AGE
WHEN USING THIS PRODUT
• KEEP OUT OF EYES, EARS AND MOUTH
• IN CASE OF CONTACT WITH EYES, RINSE EYES THPROUGHLY WITH WATER
• STOP USE AND CONTACT A PHYSICIAN IF IRRITATION OR
RASH OCCUR
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, CALL POISON CONTROL IMMEDIATELY
Do Not Use-OTC
on children less than 2 mos in age on open skin wounds.
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,
Stop Use Section
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condidtion.
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
PLACE PRODUCT IN HANDS TO COVER ALL SURFACES, RUB
TOGETHER UNTIL DRY
CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED
WHILE USING PRODUCT
INACTIVE INGREDIENTS IONIZED WATER, CARBAMIDE
Storage and Handling
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C(104F)
Inactive Ingredients
Ionized Water, Carbamide
INDICATIONS & USAGE 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 - ACTIVE INGREDIENT SECTION
BENZALKONIUM CHLORIDE 0.13% v/v..................ANTIBACTERIAL
Active Ingredients
BENZALKONIUM CHLORIDE 0.13% v/v..................ANTIBACTERIAL
Uses
HAND SANITIZER TO DECREASE BACTERIA ON THE SKIN
RECOMMENDED FOR REPEATED USE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
473ml NDC:81563-013-16
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
946ml NDC:81563-013-32
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
3785 ml NDC: 81563-013-00
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
236ml NDC: 81563-013-08
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81563-013-00 | 2023-01-30 | C162847 | 48780-1 | f386c649-9b55-0266-e053-dadaa90a7c1a | b689bda7-cade-0564-e053-2995a90a4f8a |
| 81563-013-08 | 2023-01-30 | C162847 | 48780-1 | f386c649-9b55-0266-e053-dadaa90a7c1a | b689bda7-cade-0564-e053-2995a90a4f8a |
| 81563-013-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-9b55-0266-e053-dadaa90a7c1a | b689bda7-cade-0564-e053-2995a90a4f8a |
| 81563-013-32 | 2023-01-30 | C162847 | 48780-1 | f386c649-9b55-0266-e053-dadaa90a7c1a | b689bda7-cade-0564-e053-2995a90a4f8a |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81563-013-00 | Mi | 3785 mL in 1 BOTTLE, PUMP | SOLUTION | 3785 | 1 | |
| 81563-013-08 | Mi | 236 mL in 1 BOTTLE, PUMP | SOLUTION | 236 | 1 | |
| 81563-013-16 | Mi | 473 mL in 1 BOTTLE, PUMP | SOLUTION | 473 | 1 | |
| 81563-013-32 | Mi | 946 mL in 1 BOTTLE, PUMP | SOLUTION | 946 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mi
- Benzalkonium Chloride HS
- UREA
- WATER
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81563-013 | 81563-013-08, 81563-013-16, 81563-013-32, 81563-013-00 |
| 78003-120 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| UREA | 8W8T17847W | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | 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 |
|---|---|---|---|---|---|---|
| b689bda7-cadf-0564-e053-2995a90a4f8a | b689bda7-cade-0564-e053-2995a90a4f8a | 2021-02-23 | Warnings | b689bda7-cadf-0564-e053-2995a90a4f8a b689bda7-cade-0564-e053-2995a90a4f8a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.