ADD CONDITION
Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System
Last content change checked dailysee data sync status
This product has been discontinued
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- Route
- Topical
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2016
- Label revision date
- July 24, 2019
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- Route
- Topical
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2016
- Label revision date
- July 24, 2019
- Manufacturer
- Sage Products, LLC
- Registration number
- NDA021669
- NDC root
- 53462-009
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
This medication is designed to help reduce the chance of infection in cases of minor oral irritation. It is commonly used to provide relief and support healing in the mouth, making it a helpful option for those experiencing discomfort from minor injuries or irritations. By addressing these issues, it can contribute to your overall oral health and comfort.
Uses
This medication is designed to help reduce the chance of infection in cases of minor oral irritation. If you have any irritation in your mouth, using this product can be beneficial in preventing infections that may arise from those minor issues.
It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.
Dosage and Administration
It seems that there is no specific information available regarding the dosage and administration of the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to prepare it are not provided.
If you have any questions or need guidance on how to use this medication, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.
What to Avoid
It's important to be cautious when using this product. If you accidentally swallow more than what is intended for antisepsis (the process of preventing infection), you should seek medical help immediately or contact a Poison Control Center. This ensures your safety and well-being.
Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.
Side Effects
If you experience a sore mouth that doesn't improve within 7 days, or if you develop swelling, a rash, or a fever, it's important to stop using the medication and consult your doctor. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice promptly. Your health and safety are paramount, so don't hesitate to reach out to a healthcare professional if you have any concerns.
Warnings and Precautions
If you experience a sore mouth, it's important to monitor your symptoms closely. If your sore mouth does not improve within 7 days, or if you notice any swelling, rash, or fever, you should stop using the medication and consult your doctor. Additionally, if you experience ongoing irritation, pain, or redness that worsens, it's crucial to seek medical advice.
Always prioritize your health and safety. If you have any concerning symptoms, don’t hesitate to reach out to your healthcare provider for guidance.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or contraindications related to the use of chlorhexidine gluconate during pregnancy. The information available does not indicate any risks associated with its use, and no dosage adjustments are necessary for pregnant individuals. Additionally, there are no special precautions outlined for pregnant patients regarding this medication. Always consult with your healthcare provider for personalized advice and to ensure the safety of you and your baby.
Lactation Use
If you are breastfeeding, it's important to use certain medications with caution, especially if your baby is a premature infant or younger than 2 months old. These products can potentially cause irritation or chemical burns in very young infants. Always consult with your healthcare provider before using any medication to ensure it is safe for you and your baby. Your health and your baby's well-being are the top priorities.
Pediatric Use
When using this product for children, it's important to supervise children under 12 years of age to ensure their safety. If your child is under 3 years old, you should consult a dentist or doctor before use to get specific guidance. Additionally, if you have a premature infant or an infant younger than 2 months, be cautious, as these products can potentially cause irritation or chemical burns. Always prioritize your child's safety and seek professional advice when needed.
Geriatric Use
When considering medication for older adults, it's important to be cautious, especially if you are caring for premature infants or infants under 2 months old. These medications can potentially cause irritation or chemical burns in very young children, so extra care should be taken in these situations.
Always consult with a healthcare professional to ensure that the medication is appropriate and safe for the specific needs of older adults or young infants. Your health and safety are the top priority, so don't hesitate to ask questions or express any concerns you may have.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
Drug Interactions
It's important to be aware that if you are allergic to chlorhexidine gluconate or any other ingredient in this product, you may experience a severe allergic reaction. Always discuss your allergies and any medications you are taking with your healthcare provider to ensure your safety.
Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's still crucial to keep your healthcare provider informed about all the medications and tests you are undergoing. This helps them provide the best care tailored to your needs.
Storage and Handling
To ensure the best performance of your product, store it flat in a cool, dry place. The ideal temperature range for storage is between 20-25°C (68-77°F). It's important to avoid exposing the product to excessive heat, as temperatures above 40°C (104°F) can damage it.
When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that your product remains safe and effective for use.
Additional Information
You can use this medication up to four times a day, or as directed by your dentist or doctor. If you are caring for a premature infant or an infant under 2 months old, use this medication with caution.
It's important to monitor your symptoms. If your sore mouth does not improve within 7 days, or if you experience swelling, rash, or fever, stop using the medication and consult your doctor. Additionally, if you notice any irritation, sensitization, or signs of an allergic reaction, discontinue use and seek medical help immediately. In case of accidental swallowing, contact a Poison Control Center or seek medical assistance right away.
FAQ
What is the primary use of this drug?
This drug helps reduce the chance of infection in minor oral irritation.
Are there any contraindications for this drug?
No contraindications are specified in the provided text.
What should I do if I accidentally swallow more than the recommended amount?
If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.
What should I do if my sore mouth symptoms do not improve?
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days.
Can this drug cause allergic reactions?
Yes, this product may cause a severe allergic reaction in patients allergic to chlorhexidine gluconate or any other ingredient in this product.
Is this drug safe to use during pregnancy?
The insert does not mention any contraindications or risks associated with the use of chlorhexidine gluconate during pregnancy.
How should I store this product?
Store the product flat between 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).
What precautions should I take when using this drug in children?
Supervise use in children under 12 years of age, and consult a dentist or doctor for children under 3 years of age.
How often can I use this drug?
You can use this drug up to 4 times daily or as directed by a dentist or doctor.
Packaging Info
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 3 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 —
Part 3 — Rinse
| ||||
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
This product is identified by the code 51945-4 and is associated with the effective date of July 24, 2019. The labeling includes various media representations, such as the 9009 Label, Corinz Packet, Corinz Drug Facts, and the 9707 Primary Package Label, each provided in JPEG format. The images serve to convey essential information regarding the product's packaging and usage.
Uses and Indications
This drug is indicated to help reduce the chance of infection in cases of minor oral irritation.
There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.
Dosage and Administration
No dosage and administration information is available in the provided text. Healthcare professionals are advised to consult the relevant prescribing information or product guidelines for specific dosing instructions and administration techniques.
Contraindications
There are no specified contraindications for the use of this product. However, it is important to note that if more than the recommended amount for antisepsis is accidentally ingested, immediate medical assistance should be sought or contact with a Poison Control Center is advised.
Warnings and Precautions
Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances:
Persistent Symptoms If symptoms of a sore mouth do not show improvement within 7 days, it is essential for the patient to consult a healthcare provider for further evaluation and management.
Development of New Symptoms Patients should be instructed to seek medical advice if they experience any swelling, rash, or fever during treatment, as these may indicate an adverse reaction that requires immediate attention.
Worsening Condition In cases where irritation, pain, or redness persists or worsens, it is crucial for the patient to stop using the product and consult a healthcare professional to assess the situation and determine appropriate next steps.
Monitoring for these signs is vital to ensure patient safety and effective management of any potential complications.
Side Effects
Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: sore mouth symptoms that do not improve within 7 days, the development of swelling, rash, or fever, or if irritation, pain, or redness persists or worsens. These warnings are critical for ensuring patient safety and prompt medical evaluation in the event of adverse reactions.
Drug Interactions
Patients with a known allergy to chlorhexidine gluconate or any other component of this product may experience a severe allergic reaction. It is essential for healthcare providers to assess patient history for such allergies prior to administration.
No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions is not indicated.
Packaging & NDC
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 3 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 —
Part 3 — Rinse
| ||||
Pediatric Use
Pediatric patients under 12 years of age should be supervised during use. For children under 3 years of age, it is recommended to consult a dentist or doctor prior to use. Caution is advised when administering to premature infants or infants under 2 months of age, as these products may cause irritation or chemical burns.
Geriatric Use
Elderly patients should be monitored closely when using this medication, particularly those who are premature or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration.
Healthcare providers are advised to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with the use of this medication in the elderly population.
Pregnancy
There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy. The available prescribing information does not indicate any contraindications or risks associated with the use of chlorhexidine gluconate in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The text also does not provide any special precautions regarding the use of chlorhexidine gluconate in this population. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of this agent.
Lactation
Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.
It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.
If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.
Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.
Nonclinical Toxicology
There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.
Postmarketing Experience
Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance.
Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. Special care should be taken when using this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.
Patient Counseling
Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if they accidentally swallow more than the recommended amount used for antisepsis, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with accidental overdose.
Storage and Handling
The product is supplied in a configuration that requires careful storage to maintain its integrity. It should be stored flat and kept within a temperature range of 20-25°C (68-77°F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to ensure optimal product stability and efficacy.
Additional Clinical Information
Patients may use the medication up to four times daily or as directed by a dentist or doctor. Caution is advised when administering to premature infants or infants under 2 months of age.
Clinicians should counsel patients to discontinue use and seek medical advice if sore mouth symptoms do not improve within 7 days, or if any of the following occur: swelling, rash, fever, irritation, sensitization, or signs of an allergic reaction. In the event of an allergic reaction, patients should stop use and seek immediate medical assistance. If the product is ingested, patients should contact a Poison Control Center or seek medical help promptly.
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.