ANTIBACTERIAL 1.3 mg/mL
benzalkonium chloride soap · LIQUID · Topco Associates LLC
Benzalkonium chloride soap is a topical antibacterial liquid cleanser that helps reduce bacteria on the skin. It is available over-the-counter and is commonly used for general skin cleansing and antiseptic purposes.
Key Facts
- Brand Name
- ANTIBACTERIAL
- Generic Name
- benzalkonium chloride soap
- NDC Code (Product)
76162-897- Manufacturer
- Topco Associates LLC
- Strength
- 1.3 mg/mL
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 12/18/2025
Recall History
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Midlab Incorporated
cGMP Deviations: Out of specification results for micro in hand soap products.
Beaming White Llc
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Inopak Ltd
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Inopak Ltd
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
AJR TRADING LLC
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use For handwashing to decrease bacteria on the skin
Dosage & Administration
Directions wet hands apply palmful to hands scrub thoroughly rinse thoroughly
Warnings
Warnings For external use only: hands only
Frequently Asked Questions
What is ANTIBACTERIAL used for?
Benzalkonium chloride soap is a topical antibacterial liquid cleanser that helps reduce bacteria on the skin. It is available over-the-counter and is commonly used for general skin cleansing and antiseptic purposes.
Is ANTIBACTERIAL a controlled substance?
ANTIBACTERIAL is not classified as a controlled substance by the DEA.
What is the generic name for ANTIBACTERIAL?
The generic name for ANTIBACTERIAL is benzalkonium chloride soap. There are no other listed brand versions of benzalkonium chloride soap.
What is the NDC code for ANTIBACTERIAL 1.3 mg/mL?
The NDC (National Drug Code) for ANTIBACTERIAL 1.3 mg/mL is 76162-897, listed by Topco Associates LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)