Chlorhexidine Gluconate 1.2 mg/mL
Chlorhexidine Gluconate · RINSE · Atlantic Biologicals Corps.
Chlorhexidine Gluconate is a rinse containing chlorhexidine gluconate at 1.2 mg/mL, taken oral. Manufactured by Atlantic Biologicals Corps..
Key Facts
- Brand Name
- Chlorhexidine Gluconate
- Generic Name
- Chlorhexidine Gluconate
- NDC Code (Product)
17856-2001- Manufacturer
- Atlantic Biologicals Corps.
- Strength
- 1.2 mg/mL
- Dosage Form
- RINSE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077789
- Marketing Start
- 08/01/2009
Recall History
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
CareFusion 213, LLC
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
CareFusion 213, LLC
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
CareFusion 213, LLC
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Akorn, Inc.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Akorn, Inc.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Sage Products LLC
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Akorn, Inc.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Sunstar Americas, Inc.
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
Dosage & Administration
Directions use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly
Warnings
Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water do not use routinely if you have wounds which involve more than the superficial layers of the skin Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Chlorhexidine Gluconate used for?
Chlorhexidine Gluconate contains Chlorhexidine Gluconate. It is a rinse taken oral. Consult your doctor for specific uses.
Is Chlorhexidine Gluconate a controlled substance?
Chlorhexidine Gluconate is not classified as a controlled substance by the DEA.
What is the generic name for Chlorhexidine Gluconate?
The generic name for Chlorhexidine Gluconate is Chlorhexidine Gluconate. There are 10 other brand versions of Chlorhexidine Gluconate.
What is the NDC code for Chlorhexidine Gluconate 1.2 mg/mL?
The NDC (National Drug Code) for Chlorhexidine Gluconate 1.2 mg/mL is 17856-2001, listed by Atlantic Biologicals Corps..
Other Chlorhexidine Gluconate Dosages
Other Chlorhexidine Brands
See all →- Bactoshield CHG Chlorhexidine Gluconate20 mg/mL11084-038
- Bactoshield CHG40 mg/mL11084-039
- Antiseptic Solution4 g/100mL11701-172
- Halyard Chlorhexidine Gluconate40 mg/mL39892-0960
- ReadyPrep CHG500 mg/153329-244
- NUPRO Chlorhexidine Gluconate1.2 mg/mL65222-800
- CHLORHEXIDINE GLUCONATE1.2 mg/mL0374-5080
- Antimicrobial Foam Handwash20 mg/mL21749-416
- Antiseptic Foam Handwash20 mg/mL21749-461
- Antiseptic Skin Cleanser4 mg/100mL0116-0401
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)