Indications and uses
For hand sanitizing to decrease bacteria on the skin
FiteBac Hand Sanitizer
- Manufacturer
- FiteBac SkinCare, LLC | Dhaliwal Laboratories LLC
- Effective date
- 2020-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:35:54
Label at a glance#
ProductFiteBac Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections
Dosage and administration
Use only a small, pea-sized amount as needed, which is enough to cover both your hands. Rub thoroughly over all surfaces of both hands
Storage and handling
Not intended to provide ongoing protection against new germ exposure
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Benzalkonium Chloride 0.1%
Purpose
Antimicrobial
Uses
- For hand sanitizing to decrease bacteria on the skin
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Use only a small, pea-sized amount as needed, which is enough to cover both your hands.
- Rub thoroughly over all surfaces of both hands
STORAGE AND HANDLING SECTION
- Not intended to provide ongoing protection against new germ exposure
Inactive ingredients
Cyclopentasiloxane, Dimethicone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate
Questions, comments, side effects or reordering
770-218-6221
SPL UNCLASSIFIED SECTION
Distributed by FiteBac SkinCare, LLC, Marietta, Georgia 30064
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13136-002-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e876-a426-e053-dadaa90af4c2 | FiteBac Hand Sanitizer |
| 13136-002-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e876-a426-e053-dadaa90af4c2 | FiteBac Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13136-002-01 | FiteBac Hand Sanitizer | 85 g in 1 TUBE | GEL | 85 | 2 | |
| 13136-002-02 | FiteBac Hand Sanitizer | 1000 g in 1 BOTTLE, PLASTIC | GEL | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- FiteBac Hand Sanitizer
- Benzalkonium Chloride
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- BENZALKONIUM
- PPG-3 BENZYL ETHER ETHYLHEXANOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13136-002 | 13136-002-01, 13136-002-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) | UF7620L1W6 | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| PPG-3 BENZYL ETHER ETHYLHEXANOATE | 3N703GY99W | 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 |
|---|---|---|---|---|---|---|
| b76af010-2938-6613-e053-2995a90ab417 | 84d1211a-08c1-7abb-e053-2a91aa0a62b7 | 2020-12-26 | Warnings | b76af010-2938-6613-e053-2995a90ab417 84d1211a-08c1-7abb-e053-2a91aa0a62b7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.