Hand Sanitizer with Additive
- Manufacturer
- Tropical Enterprises International, Inc.
- Effective date
- 2020-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:36:21
Label at a glance#
ProductHand Sanitizer with Additive
Active ingredientALCOHOL
Label structure14 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Ethyl Alcohol 70% v/v
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor if irritation and redness develops and persists.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children: If swallowed, seek prompy medical attention.
OTC - PURPOSE SECTION
Uses: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
OTC - QUESTIONS SECTION
Questions: 1-800-535-5053
OTC - STOP USE SECTION
OTC - WHEN USING SECTION
DOSAGE & ADMINISTRATION SECTION
Directions: Wet hands thoroughly with product and allow to dry without wiping.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Silicon Quaternary Ammonia Salt .75%, Water, Carbomer, Triethanolamine
WARNINGS SECTION
WARNINGS: For external use only
SAFE HANDLING WARNING SECTION
Flammable: Keep away from open flame. Avoid freezing and excessive heat about 40C.
OTHER SAFETY INFORMATION
Other information: Non-staining, may discolor certain fabrics.
INDICATIONS & USAGE SECTION
Uses: For handwashing to decrease bacteria on the skin.
When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58418-119-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4d73-a426-e053-dadaa90af4c2 | Formula # HM4005-01 70% Ethyl Alcohol Hand Sanitizer Gel with Spar additive. |
| 58418-119-64 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4d73-a426-e053-dadaa90af4c2 | Formula # HM4005-01 70% Ethyl Alcohol Hand Sanitizer Gel with Spar additive. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58418-119-08 | Hand Sanitizer with Additive | 240 mL in 1 BOTTLE, PUMP | GEL | 240 | 1 | |
| 58418-119-64 | Hand Sanitizer with Additive | 3840 mL in 1 BOTTLE, PUMP | GEL | 3840 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer with Additive
- WATER
- CARBOMER 1342
- TROLAMINE
- OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58418-119 | 58418-119-08, 58418-119-64 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| CARBOMER 1342 | 809Y72KV36 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE | GLJ50K866T | 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 |
|---|---|---|---|---|---|---|
| b7c7d5cd-a295-8898-e053-2995a90a482c | b7c7d5cd-a294-8898-e053-2995a90a482c | 2020-12-31 | Warnings | b7c7d5cd-a295-8898-e053-2995a90a482c b7c7d5cd-a294-8898-e053-2995a90a482c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.