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Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System
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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
- February 7, 2017
- 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
- February 7, 2017
- Manufacturer
- Sage Products, LLC
- Registration number
- NDA021669
- NDC root
- 53462-110
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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Drug Overview
Nose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System is a product designed to help you maintain oral hygiene and skin cleanliness. It aids in the removal of dental plaque, debris, and secretions, which can contribute to minor oral irritation. By using this system, you can also help reduce the chance of infection in these areas, promoting overall health and well-being.
Uses
You can use this product to help keep your mouth healthy by aiding in the removal of dental plaque, debris, and secretions. This is important because it helps reduce the chance of infection, especially in cases of minor oral irritation. By maintaining good oral hygiene, you can support your overall dental health and prevent potential issues.
Dosage and Administration
It seems that there is no specific dosage or administration information available for this medication. This means that details about how much to take, how to take it, or how often to use it are not provided in the insert.
If you have any questions or need guidance on how to use this medication, it's important to consult with your healthcare provider. They can give you the necessary instructions tailored to your individual needs. Always follow their advice to ensure safe and effective use of the medication.
What to Avoid
It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care when using it.
If you accidentally swallow more than what is intended for antisepsis, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.
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 for help 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 any irritation, pain, or redness that persists or 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 there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.
If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control center can provide you with the guidance you need.
Pregnancy Use
While the information provided does not specify any particular warnings or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.
Since there are no specific precautions mentioned regarding the use of this medication during pregnancy, maintaining open communication with your doctor is key. They can help you weigh the benefits and risks to ensure the best outcomes for you and your baby.
Lactation Use
When 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 even 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 nursing baby. Your baby's safety is the top priority, so taking these precautions can help protect their health while you continue to breastfeed.
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 professional advice tailored to their needs. Additionally, be cautious if you have a premature infant or an infant younger than 2 months, as these products can potentially cause irritation or chemical burns. Always prioritize your child's safety and well-being when considering any medication or treatment.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.
Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive 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 the product remains safe and effective for your use.
Additional Information
You can use this product 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 it with caution. Remember to discard each cloth after a single use.
If you notice that sore mouth symptoms do not improve within 7 days, or if you experience swelling, rash, or fever, stop using the product and consult a doctor. Additionally, if you experience any irritation, sensitization (a heightened sensitivity to the product), or allergic reactions, seek medical advice. In case of accidental swallowing, get medical help or contact a Poison Control Center immediately.
FAQ
What is Nose to Toes used for?
Nose to Toes aids in the removal of dental plaque, debris, and secretions, and helps reduce the chance of infection in minor oral irritation.
What should I do if I accidentally swallow Nose to Toes?
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.
Are there any age restrictions for using Nose to Toes?
Children under 12 years of age should be supervised during use, and those under 3 years should consult a dentist or doctor.
How should I store Nose to Toes?
Store the product flat between 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).
Can Nose to Toes be used in infants?
Use with care in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.
How often can I use Nose to Toes?
You can use Nose to Toes up to 4 times daily or as directed by a dentist or doctor.
What should I do if I experience irritation or an allergic reaction?
Stop use and ask a doctor if irritation, sensitization, or an allergic reaction occurs.
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 4 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 — Rinse
Part 3 —
Part 4 — Solution
| ||||
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
Nose to Toes is a comprehensive system designed for skin antisepsis, oral cleansing, and nasal antisepsis. The system includes various components, each identified by specific reference values for labeling and documentation. The effective date of this formulation is February 7, 2017.
The system is accompanied by a Nose to Toes label, identified as N2T_9010_R4751_Label.jpg, which provides essential information regarding its use and efficacy. Additionally, a CHG label, referenced as N2T_9010_R5335D_CHGLabel.jpg, outlines the chlorhexidine gluconate (CHG) content and its antiseptic properties.
The Corinz Burst Pouch, referenced as N2T_9010_R5439_Corinzpckt.jpg, serves as the packaging for the system, ensuring the integrity and sterility of the components. Furthermore, the Corinz Drug Facts, identified as N2T_9010_R5496_drugfacts.jpg, provide detailed information on the active ingredients, indications, and usage instructions.
Uses and Indications
This drug is indicated for the removal of dental plaque, debris, and secretions. It aids in reducing the risk of infection associated with minor oral irritation.
Dosage and Administration
There is currently no specific dosage or administration information available for this product. Additionally, no details regarding the route, method, or frequency of administration have been provided in the prescribing information. Healthcare professionals are advised to consult relevant clinical guidelines or additional resources for further information on appropriate dosing and administration practices.
Contraindications
There are no specific contraindications listed for this product. However, it is important to note that if more than the recommended amount used for antisepsis is accidentally swallowed, 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
There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.
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 4 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 — Rinse
Part 3 —
Part 4 — Solution
| ||||
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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.
Pregnancy
The use of this medication during pregnancy has not been specifically addressed in the available data. There are no warnings related to pregnancy included in the prescribing information, nor are there any dosage modifications recommended for pregnant individuals. Additionally, no special precautions regarding the use of this medication during pregnancy have been provided. Healthcare professionals should consider the lack of specific data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks.
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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse effects when this product is used by lactating mothers.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.
Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.
Nonclinical Toxicology
No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.
Postmarketing Experience
Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: irritation, sensitization, and allergic reactions. These reactions may be indicative of a serious condition.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the patient accidentally swallows more than the recommended amount 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 from misuse.
Storage and Handling
The product is supplied in a configuration that requires careful storage to maintain its integrity. It should be stored flat to prevent any potential damage. The recommended storage temperature range is between 20-25°C (68-77°F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), as this may compromise the product's quality. Proper handling and adherence to these storage conditions are essential for ensuring the product remains effective and safe for use.
Additional Clinical Information
Patients may use the product 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. Each cloth should be discarded after a single use.
Clinicians should counsel patients to discontinue use and seek medical advice if sore mouth symptoms do not improve within 7 days, or if any swelling, rash, or fever develops. Additionally, patients should be advised to stop use and consult a doctor if irritation, sensitization, or an allergic reaction occurs. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.
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.