Indications and uses
Hand Sanitizer to to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
GEA Cosmetics Labs Hand and Body Sanitizer
- Manufacturer
- Romano Group, LLC
- Effective date
- 2021-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:40
Label at a glance#
ProductGEA Cosmetics Labs Hand and Body Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections
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.
Label contents#
Full prescribing information#
Active Ingredient
Benzalkonium Chloride 0.13%
Purpose
Antiseptic
Uses
Hand Sanitizer to to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For External Use only.
Do Not Use
On children less that 2 months of age
on open skin wounds
When using this product
keep out of eyes, ears, and mouth, in case of contact with eyes, rinse eyes thoroughly with water
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- 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.
Other Information
Store between 15-30C (59-86F)
Avoid Freezing and excessive heat above 40C (104F)
Inactive Ingredients
Ionized water, Carbamide
GEA Cosmetics Labs Hand & Body Sanitizer
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81237-001-10 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b214-d8a0-e053-dadaa90a6e4e | GEA Cosmetics Labs Hand & Body Sanitizer |
| 81237-001-16 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b214-d8a0-e053-dadaa90a6e4e | GEA Cosmetics Labs Hand & Body Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81237-001-10 | GEA Cosmetics Labs Hand and Body Sanitizer | 3785 mL in 1 BOTTLE | SPRAY | 3785 | 1 | |
| 81237-001-16 | GEA Cosmetics Labs Hand and Body Sanitizer | 472 mL in 1 BOTTLE | SPRAY | 472 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- GEA Cosmetics Labs Hand and Body Sanitizer
- Benzalkonium Chloride 0.13%
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- WATER
- UREA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81237-001 | 81237-001-16, 81237-001-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| UREA | 8W8T17847W | IACT |
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 |
|---|---|---|---|---|---|---|
| b6fbff99-6710-6837-e053-2a95a90a6d7f | b6fc0cc8-fefb-6835-e053-2a95a90a899c | 2021-01-01 | Warnings | b6fbff99-6710-6837-e053-2a95a90a6d7f b6fc0cc8-fefb-6835-e053-2a95a90a899c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.