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Ikonik Tonik

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2024
Label revision date
January 14, 2025
Manufacturer
IKONIK CARE, LLC
Registration number
M017
NDC root
85132-001
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

IKONCream-3 is a topical cream designed to provide temporary relief from pain and itching caused by minor cuts and skin irritations. It can be a helpful option for soothing discomfort associated with these common skin issues, allowing you to feel more comfortable as you heal.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor cuts and minor skin irritations. It helps soothe discomfort and promotes a more comfortable healing process.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this cream, it's important to follow the directions provided. Start by cleaning and drying the area where you will apply the cream. For adults and children aged 2 years and older, you should apply a thin layer to the affected area no more than 3 to 4 times a day. Be careful not to rub the cream in; just let it sit on the skin.

If the user is a child under 2 years old, do not use the cream without first consulting a doctor. After applying the cream, wash your hands thoroughly unless you are treating your hands. Additionally, avoid covering the treated area with a bandage or wrap unless your doctor specifically tells you to do so.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return shortly after. Additionally, if you experience an allergic reaction—such as increased redness, irritation, swelling, or pain—you should seek medical advice immediately.

This product is for external use only, and you should avoid applying it to large areas, especially on raw surfaces, blistered areas, deep puncture wounds, or serious burns. Be cautious to keep it away from your eyes, mouth, and mucous membranes, and avoid excessive or prolonged use, as this may increase the risk of side effects. If you are pregnant or breastfeeding, consult a healthcare professional before using this product. If swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas, especially on raw surfaces, blistered skin, deep puncture wounds, or serious burns. While using this product, be careful to keep it away from your eyes, mouth, and mucous membranes, and avoid using it excessively or for long periods, as this can increase the risk of side effects.

If your condition worsens, symptoms last more than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience any signs of an allergic reaction, such as increased redness, irritation, swelling, or pain, seek medical advice. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is 2 years old or older, you can apply a thin layer of the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Always ensure you follow these guidelines to keep your child safe and healthy.

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 elderly patients may have different health needs and responses to medications, it’s always a good idea to 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.

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 for the medication do not change based on liver impairment. However, it’s always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice 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 tests to ensure your liver is functioning well while you are on any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your 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 concerns you may have regarding your medications or tests. Your safety and well-being are the top priorities, and discussing these topics can help prevent any potential issues down the line.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, away from direct sunlight. This helps maintain its quality. The package is designed to be child-resistant, providing an extra layer of safety for households with children. Always handle the product with care to avoid any damage or contamination.

Additional Information

You should apply a thin layer of the medication to the affected area on your skin, no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this medication without consulting a doctor first.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is IKONCream-3 used for?

IKONCream-3 is used for the temporary relief of pain and itching associated with minor cuts and minor skin irritations.

How should I apply IKONCream-3?

You should apply a thin layer to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. Clean and dry the area before application.

Can I use IKONCream-3 on children under 2 years of age?

No, do not use IKONCream-3 on children under 2 years of age without consulting a doctor.

What precautions should I take when using IKONCream-3?

Avoid contact with the eyes, mouth, or mucous membranes, and do not use in large quantities on raw surfaces, blistered areas, deep puncture wounds, or serious burns.

What should I do if I experience an allergic reaction?

Stop using IKONCream-3 and ask a doctor if you experience an allergic reaction, or if redness, irritation, swelling, or pain increases.

Is IKONCream-3 safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using IKONCream-3.

What should I do if IKONCream-3 is swallowed?

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

How should I store IKONCream-3?

Store IKONCream-3 at room temperature, away from direct sunlight, and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Ikonik Tonik (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ikonik Tonik.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

IKONCream-3 is a topical formulation designed for dermatological use. The product is presented in a cream dosage form, facilitating application to the skin. Specific details regarding its chemical composition, molecular weight, and inactive ingredients are not provided in the extracted data. The formulation is intended for professional use in clinical settings, adhering to established standards for topical medications.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor cuts and minor skin irritations.

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

Dosage and Administration

The product should be used only as directed. Prior to application, the affected area must be cleaned and dried thoroughly. For adults and children aged 2 years and older, a thin layer of the cream should be applied to the affected area no more than 3 to 4 times daily. It is important to avoid rubbing the cream into the skin.

For children under 2 years of age, the product should not be used without consulting a doctor. After application, hands should be washed thoroughly unless the product is being applied to the hands. Additionally, the treated area should not be covered with a bandage or wrap unless specifically instructed by a healthcare professional.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, particularly on raw surfaces, blistered areas, deep puncture wounds, or serious burns.

When utilizing this product, it is imperative to avoid contact with the eyes, mouth, or mucous membranes. Additionally, excessive use or prolonged application should be avoided, as overuse may increase the risk of side effects.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. An immediate consultation is also necessary if an allergic reaction occurs, or if there is an increase in redness, irritation, swelling, pain, or other concerning symptoms.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use.

This product must be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be applied in large quantities, particularly on raw surfaces, blistered areas, deep puncture wounds, or serious burns. It is important to avoid contact with the eyes, mouth, or mucous membranes during use. Excessive use or prolonged application may increase the risk of adverse reactions.

Participants are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if any signs of an allergic reaction occur, such as increased redness, irritation, swelling, or pain, medical advice should be sought immediately.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay. Special caution is advised for pregnant or breastfeeding individuals, who should consult a healthcare professional prior to use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Ikonik Tonik (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ikonik Tonik.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin layer of the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels. Individuals are encouraged to report any serious adverse events to the designated phone number provided for this purpose. The reporting service is available Monday through Friday from 9:30 AM to 5:30 PM.

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 medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

This product is supplied in a child-resistant package, ensuring safety during storage and handling. It should be stored at room temperature, away from direct sunlight, to maintain its integrity and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Ikonik Tonik, 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 Ikonik Tonik, 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.