Active Ingredients
Chlorhexidine gluconate,（ 2% solution ） ，
Isopropyl alcohol,（ 70% solution ）
Chlorhexidine Gluconate Applicator
FDA Label NDC 73565-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miraclean Technology Co.,ltd for the product Chlorhexidine Gluconate Applicator (NDC 73565-011). 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 active ingredients, ask a doctor, do not use, keep out of the reach of children, purpose, stop use and ask a doctor, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctor
If any irritation or allergic reaction occurs
Do Not Use
■ If any open wounds
■ If package damaged or expired
■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
Keep Out Of The Reach Of Children
Keep out of the reach of children
Purpose
Antiseptic
Stop Use And Ask A Doctor
If any irritation or allergic reaction occurs
Inactive Ingredient
■ Water
Other Information
■ Stored between 4-30℃
Avoid exclusive heat above 40℃ (104° F)
Directions
Peel apart the package and remove the applicator
Pull and remove the ring collar lock from the handle
Wet the treatment area with the fluid
Press down the handle to activate and release the solution flow into the sponge pad
Use
For skin preparation before surgery
Warnings
■ Single-use product
■ Keep away from flames or sparks
■ Keep out of the reach of children
Label
10.5g (10.5g)
26g (26g)
* Please review the disclaimer below.
