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Ocean Potion Suncare Ice Plus Pain Relieving Soothing

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Active ingredient
Lidocaine Hydrochloride 8 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 8 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2025
Label revision date
August 15, 2025
Manufacturer
GNL BRANDS INTERNATIONAL, LLC
Registration number
M017
NDC root
85638-005
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 provide temporary relief from pain and itching caused by various skin issues, including sunburn, minor burns, cuts, scrapes, insect bites, and other minor skin irritations. It helps soothe discomfort and promote a sense of relief when you experience these common skin problems.

Uses

If you're dealing with discomfort from sunburn, minor burns, cuts, scrapes, insect bites, or other minor skin irritations, this product can help provide temporary relief from pain and itching. It's designed to soothe your skin and make you feel more comfortable during the healing process.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this product, making it a safe option for many users.

Dosage and Administration

When using this medication, you should apply it to the affected area of your skin no more than 3 to 4 times a day. This guideline applies to both adults and children who are 2 years old and older. If you have a child who is under 2 years of age, it’s important to consult with a doctor before using this medication to ensure it’s safe and appropriate for them. Always follow these instructions carefully to achieve the best results.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If you notice that your condition is getting worse, or if your symptoms last longer than seven days, you should stop using the product and consult a doctor. Additionally, if your symptoms improve but then return within a few days, it's advisable to seek medical advice.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center right away. It's important not to use large amounts, especially on raw or blistered skin.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Additionally, avoid getting the product in your eyes; if this happens, rinse your eyes with water immediately.

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 if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of using this product during pregnancy has not been established. It is generally not recommended for pregnant women due to potential risks to the developing fetus. If you are considering using it, please consult your healthcare provider for personalized advice.

Additionally, if you are pregnant, your doctor may suggest dosage adjustments to ensure safety. Always discuss any use of this product with your healthcare provider before applying it, as they can provide guidance tailored to your specific situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center right away. Your child's safety is the top priority, so follow these guidelines carefully.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions for your specific treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. Your safety and well-being are the top priority, and discussing all aspects of your treatment helps to achieve the best outcomes.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I use the drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, you should ask a doctor.

Are there any contraindications for using this drug?

There are no specific contraindications mentioned, but it is advised not to use it in large quantities, especially over raw surfaces or blistered areas.

What should I do if I experience worsening symptoms?

You should stop using the drug and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Is it safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks. Consult your healthcare provider for advice.

What precautions should I take if I swallow the drug?

If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store the drug?

Store the drug at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed. Discard it after opening.

Can I use this drug if I have kidney problems?

Renal impairment may necessitate dosage adjustments, and renal function tests should be monitored in patients with kidney problems.

What should I do if the drug comes into contact with my eyes?

If the drug comes into contact with your eyes, rinse with water to remove it.

Packaging Info

Below are the non-prescription pack sizes of Ocean Potion Suncare Ice Plus Pain Relieving Soothing (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ocean Potion Suncare Ice Plus Pain Relieving Soothing.
Details

Drug Information (PDF)

This file contains official product information for Ocean Potion Suncare Ice Plus Pain Relieving Soothing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use. This precaution ensures that appropriate guidance is provided based on the individual needs of the child.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified in the provided data.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Caution is advised regarding the application of this product; it should not be used in large quantities, especially on raw surfaces or blistered areas.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, it is crucial to avoid contact with the eyes. Should contact occur, the affected area should be rinsed thoroughly with water to ensure complete removal of the product.

Side Effects

Patients should be aware that the product is intended for external use only. In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, it is advised to stop use and consult a healthcare professional. These warnings are important to ensure the safety and well-being of patients using the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Ocean Potion Suncare Ice Plus Pain Relieving Soothing (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ocean Potion Suncare Ice Plus Pain Relieving Soothing.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks associated with its use. There may be risks to the fetus, and it is advised that pregnant patients consult their healthcare provider for personalized advice regarding the use of this product.

Dosage adjustments may be necessary for pregnant individuals; therefore, medical guidance should be sought to determine the appropriate dosage. Pregnant women are encouraged to discuss the use of this product with their healthcare provider prior to application to ensure safety for both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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 substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially over raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. In the event of accidental eye contact, patients should rinse their eyes with water to remove the product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ocean Potion Suncare Ice Plus Pain Relieving Soothing, 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 Ocean Potion Suncare Ice Plus Pain Relieving Soothing, 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.