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Pure Primal Delay

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
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 2025
Label revision date
July 28, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
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 2025
Label revision date
July 28, 2025
Manufacturer
Prodigy Media Inc
Registration number
M017
NDC root
70171-0060
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

PURE PRIMAL DELAY is a product designed to provide temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and various skin irritations. It aims to soothe discomfort and help you feel more comfortable during these common skin issues.

Uses

If you're dealing with discomfort from sunburns, minor cuts, insect bites, or skin irritations, this medication can help provide temporary relief from pain and itching. It's designed to soothe your skin and make you feel more comfortable during these minor irritations.

You can use it as needed to alleviate those bothersome symptoms, allowing you to get back to your daily activities with less discomfort. Remember, it's always a good idea to consult with a healthcare professional if you have any concerns about your skin or the use of this product.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a physician (a medical doctor). Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety, as prompt action can help prevent potential harm.

Currently, there are no listed contraindications, risks of abuse or misuse, or concerns about dependence associated with this product. Always follow the guidance provided to ensure safe usage.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and consult a doctor. It's important to avoid using large amounts, especially on raw or blistered areas, and to stick to the recommended daily dosage unless your doctor advises otherwise. Additionally, do not apply this product to wounds or damaged skin.

Warnings and Precautions

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

You should stop using the product and consult your doctor if your condition worsens or if symptoms persist for more than 7 days. Additionally, if your symptoms improve and then return within a few days, it's important to reach out to your healthcare provider. Be cautious not to use large amounts, especially on raw or blistered skin, and do not apply it to wounds or damaged areas. Always follow the recommended dosage unless your doctor advises otherwise.

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

It’s important to be cautious when considering any medication during pregnancy. For PURE PRIMAL DELAY (lidocaine hcl cream), there is currently no information available about its use during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product to ensure it’s safe for you and your baby. Always prioritize open communication with your doctor about any medications you are considering.

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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 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 physician (a medical doctor).

Always remember to keep this medication out of reach of children to ensure their safety. If you have any questions or concerns about its use, don’t hesitate to reach out to your healthcare provider for guidance.

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 considering this medication, it’s important to consult with a healthcare provider. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the packaging before use; do not use the product if the seal is broken, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its integrity.

Additional Information

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

FAQ

What is PURE PRIMAL DELAY used for?

PURE PRIMAL DELAY is used for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations.

How should I apply PURE PRIMAL DELAY?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a physician.

Are there any contraindications for using PURE PRIMAL DELAY?

There are no specific contraindications listed for PURE PRIMAL DELAY.

What should I do if I swallow PURE PRIMAL DELAY?

If the product is swallowed, you should get medical help or contact a Poison Control Center right away.

What precautions should I take when using PURE PRIMAL DELAY?

Use PURE PRIMAL DELAY for external use only, avoid contact with eyes, and do not use on wounds or damaged skin.

What should I do if my condition worsens or symptoms persist?

You should stop using PURE PRIMAL DELAY and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is there any information about using PURE PRIMAL DELAY during pregnancy or while nursing?

There is no specific information provided regarding the use of PURE PRIMAL DELAY during pregnancy or while nursing.

How should I store PURE PRIMAL DELAY?

Store PURE PRIMAL DELAY at room temperature and do not use it if the seal is broken.

Packaging Info

Below are the non-prescription pack sizes of Pure Primal Delay (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pure Primal Delay.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and 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, the product should not be used without consulting a physician. Healthcare professionals are advised to evaluate the necessity and safety of treatment in this age group before proceeding with any application.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days. It is crucial to emphasize that the product should not be applied in large quantities, especially over raw surfaces or blistered areas, and that the recommended daily dosage should not be exceeded unless directed by a healthcare provider.

Additionally, this product is contraindicated for use on wounds or damaged skin. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. It is crucial to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought.

The product should not be used in large quantities, especially over raw surfaces or blistered areas, and the recommended daily dosage should not be exceeded unless directed by a healthcare professional. Furthermore, it is important to refrain from using the product on wounds or damaged skin to prevent potential adverse reactions.

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 Pure Primal Delay (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pure Primal Delay.
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, the use of this medication is not recommended, and consultation with a physician is advised. It is important to keep the medication out of reach of children to ensure safety.

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, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of PURE PRIMAL DELAY (lidocaine hcl cream) 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 in this population. 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 are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

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 that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of accidental ingestion.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature to maintain its integrity and efficacy. Healthcare professionals are advised to ensure that the product is not used if the seal is broken, as this may compromise the safety and effectiveness of the product. Proper handling and storage conditions are essential to ensure optimal performance.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Pure Primal Delay, 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 Pure Primal Delay, 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.