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Sato Clear

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Active ingredient
Naphazoline Hydrochloride 12 mg/100 mL
Other brand names
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1989
Label revision date
November 28, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Naphazoline Hydrochloride 12 mg/100 mL
Other brand names
Dosage form
Solution/ Drops
Route
Ophthalmic
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 1989
Label revision date
November 28, 2023
Manufacturer
Sato Pharmaceutical Co. , Ltd.
Registration number
M018
NDC root
49873-044
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 relieve symptoms caused by minor eye irritations, such as redness. It works by targeting the underlying causes of these symptoms, helping to soothe and calm your eyes. If you're experiencing discomfort or redness in your eyes, this treatment may provide the relief you need.

Uses

If you're experiencing minor eye irritations that cause redness, this medication can help relieve that discomfort. It's specifically designed to address the redness associated with these irritations, providing you with a clearer and more comfortable vision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate minor eye redness without additional concerns.

Dosage and Administration

To use this eye medication, you should place 1 or 2 drops directly into the affected eye. You can do this up to 4 times a day, depending on your needs. Make sure to follow this schedule to help manage your symptoms effectively. If you have any questions about how to use the drops or how often to apply them, don’t hesitate to ask your healthcare provider for guidance.

What to Avoid

It’s important to ensure the safety and effectiveness of your medication. You should not use the solution if it changes color or becomes cloudy, as this indicates that it may no longer be safe to take. Always check the appearance of your medication before use to avoid any potential risks. If you notice any changes, please consult your healthcare provider for further guidance.

Side Effects

When using this product, be aware that it is for external use only. You may notice that your pupils become temporarily enlarged, and overusing the product can lead to increased redness in your eyes. To keep the product clean, avoid touching the tip of the container to any surface and remember to replace the cap after each use.

If you experience any eye pain, changes in your vision, ongoing redness or irritation, or if your condition worsens or lasts more than 72 hours, stop using the product and consult a doctor. Additionally, if you have narrow angle glaucoma, it's important to ask your doctor before using this product.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

Before using this product, consult your doctor if you have narrow angle glaucoma, as it may not be suitable for you. If you experience any of the following issues, stop using the product and contact your doctor: eye pain, changes in vision, ongoing redness or irritation of the eye, or if your condition worsens or lasts longer than 72 hours.

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 signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using Sato Clear (naphazoline hydrochloride solution/drops) during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication. They can help you understand any potential risks and guide you on the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may consider during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of Sato Clear (naphazoline hydrochloride solution/drops) for nursing mothers. This means that the effects of this medication on breast milk and your nursing infant are not well-studied or documented.

As always, it's best to consult with your healthcare provider before using any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

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 before starting the medication. 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 the 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 discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the tamper-resistant seal on the bottle cap is intact before use. This seal helps confirm that the product has not been compromised. Additionally, make sure to keep the container tightly closed when not in use to protect its contents from contamination and maintain its quality.

By following these simple steps, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug relieves symptoms due to minor eye irritations, specifically redness of the eye.

How should I use this drug?

Place 1 or 2 drops in the affected eyes up to 4 times daily. To avoid contamination, do not touch the tip of the container to any surface and replace the cap after use.

Are there any contraindications for this drug?

Do not use this drug if the solution changes color or becomes cloudy.

What should I do if I experience eye pain or changes in vision?

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Is this drug safe for use during pregnancy?

There is no specific information provided regarding the use of this drug during pregnancy.

What should I do if I swallow this drug?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this drug if I have narrow angle glaucoma?

You should ask a doctor before using this product if you have narrow angle glaucoma.

What are the warnings associated with this drug?

This drug is for external use only. Overuse may produce increased redness of the eyes.

How should I store this drug?

Keep the container tightly closed and out of reach of children. Use only if the imprinted tamper-resistant seal on the bottle cap is intact.

Packaging Info

Below are the non-prescription pack sizes of Sato Clear (naphazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sato Clear.
Details

Drug Information (PDF)

This file contains official product information for Sato Clear, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is packaged in a carton and is represented in a media type of image/jpeg. The reference image for the product is identified as satoclearcart.jpg.

Uses and Indications

This drug is indicated for the relief of redness of the eye due to minor eye irritations.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to administer 1 to 2 drops of the medication in the affected eyes. This can be done up to four times daily, depending on the severity of the condition being treated. It is important to ensure that the drops are applied directly into the conjunctival sac of the eye for optimal efficacy.

Contraindications

Use of this product is contraindicated if the solution changes color or becomes cloudy. This alteration may indicate degradation of the product, which could compromise safety and efficacy.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have narrow angle glaucoma, as this condition may exacerbate potential side effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients are instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms: eye pain, changes in vision, persistent redness or irritation of the eye, or if the condition worsens or does not improve within 72 hours. Monitoring for these symptoms is essential to ensure patient safety and effective management of any adverse reactions.

Side Effects

Patients using this product should be aware that it is for external use only. Prior to use, individuals with narrow angle glaucoma should consult a doctor.

During the use of this product, participants may experience temporary pupil enlargement. Additionally, overuse may lead to increased redness of the eyes. To prevent contamination, it is advised that users avoid touching the tip of the container to any surface and ensure the cap is replaced after each use.

Patients are instructed to discontinue use and seek medical advice if they experience any of the following adverse reactions: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Sato Clear (naphazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sato Clear.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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

There is no information available regarding the use of Sato Clear (naphazoline hydrochloride solution/drops) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There is no specific information available regarding the use of Sato Clear (naphazoline hydrochloride solution/drops) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing 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, specific antidotes or treatments should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for guidance on the management of the overdose and to obtain further recommendations tailored to the specific situation.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if the solution changes color or becomes cloudy, as this may indicate a loss of efficacy or safety. It is important to counsel patients to stop using the product and consult a doctor if they experience any of the following: eye pain, changes in vision, continued redness or irritation of the eye, or if their condition worsens or persists for more than 72 hours.

While using the product, patients should be made aware that their pupils may become temporarily enlarged and that overuse may lead to increased redness of the eyes. To prevent contamination, patients should be instructed not to touch the tip of the container to any surface and to replace the cap after each use.

Additionally, healthcare providers should recommend that patients consult a doctor before using the product if they have narrow angle glaucoma, as this condition may affect the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in containers that feature an imprinted tamper-resistant seal on the bottle cap. It is essential to use the product only if this seal is intact. To ensure the integrity of the product, the container must be kept tightly closed when not in use.

Proper storage conditions are crucial for maintaining the product's efficacy. It should be stored in a cool, dry place, away from direct sunlight and moisture. Adhering to these guidelines will help preserve the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sato Clear, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sato Clear, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.