Otc - Active Ingredient
Active Ingredient
Chlorhexidine Diacetate 1%
Serdaen
FDA Label NDC 56149-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Browne Hansen Llc for the product Serdaen (NDC 56149-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients
Water, Cola Det SDC, Sodium Xylem Sulfate, Tocopheryl Acetate, Fragrance
Otc - Purpose
Purpose
Antimicrobial
Indications & Usage
Uses
Prevent overgrowth of bacteria prior to surgical procedure
Prevent recurrent bacterial infections
Prevent infections around superficial wounds
Otc - 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.
Warnings
Warnings
For external use only.
Do not use:
If allergic to Chlorhexidine or other ingredients in formulation
In contact with the genital area
On wounds that exceed the superficial layer of skin.
Otc - When Using
When using this product
Avoid eye contact. Should contact occur,
rinse thoroughly with water.
Otc - Stop Use
Discontinue use and consult a health care practitioner
if irritation or allergic reaction develops.
Dosage & Administration
Directions
Apply liberally to moistened area, wash and rinse thoroughly.
All product should be rinsed and dried immediately
Package Label.Principal Display Panel
Copy Of Label (Serdaen One)
* Please review the disclaimer below.
