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Lip Medex Lip Balm
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- Active ingredients
- Petrolatum 42 g/100 g
- Phenol 0.6 g/100 g
- Menthol, Unspecified Form 1 g/100 g
- Camphor (synthetic) 1 g/100 g
- Other brand names
- Dosage form
- Stick
- 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
- July 1, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Petrolatum 42 g/100 g
- Phenol 0.6 g/100 g
- Menthol, Unspecified Form 1 g/100 g
- Camphor (synthetic) 1 g/100 g
- Other brand names
- Dosage form
- Stick
- 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
- July 1, 2024
- Manufacturer
- Blistex Inc.
- Registration number
- M017
- NDC root
- 10157-1194
- Drug Information (PDF)
- Prescribing information, PDF file
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
Blistex® Lip Medex® is a dermatologist-recommended lip protectant and external analgesic designed to provide instant moisturization for your lips. It helps prevent future dryness while quickly cooling and comforting dry, sore lips. This product is effective for the temporary relief of pain and itching associated with minor lip irritation and offers protection against chapped or cracked lips.
Additionally, Blistex® Lip Medex® helps shield your lips from the drying effects of wind and cold weather, making it a great choice for maintaining lip health in various conditions. Each pack contains three sticks, ensuring you have plenty on hand to keep your lips feeling soft and protected.
Uses
If you're dealing with minor lip irritation, this product can provide temporary relief from pain and itching. It’s also effective in protecting and soothing chapped or cracked lips, helping to restore comfort.
Additionally, it offers a protective barrier against the drying effects of wind and cold weather, ensuring your lips stay hydrated and healthy.
Dosage and Administration
If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.
For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice for the best outcomes.
What to Avoid
It's important to use this product safely to avoid potential complications. You should not use it on deep or puncture wounds, animal bites, or serious burns, as these conditions can lead to serious issues. Additionally, be careful not to get the product in your eyes, and avoid applying it over large areas of your body or covering it with a bandage.
Using this product improperly can lead to misuse or abuse, which may result in dependence (a condition where your body becomes reliant on a substance). Always follow these guidelines to ensure your safety and well-being.
Side Effects
When using this product, it's important to be aware of certain precautions. This product is for external use only, so avoid applying it to deep or puncture wounds, animal bites, or serious burns. Be careful not to get it in your eyes, and do not cover large areas of your body or bandage the area where it is applied.
If your condition worsens, or if symptoms persist for more than 7 days or return after clearing up, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.
Warnings and Precautions
This product is for external use only, so please avoid applying it to deep or puncture wounds, animal bites, or serious burns. When using it, be careful not to get it in your eyes, and do not apply it over large areas of your body or cover it with a bandage.
If your condition worsens, or if your symptoms last more than 7 days or improve and then come back within a few days, stop using the product and consult your doctor. Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.
Overdose
If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.
Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. Always err on the side of caution and get help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to reach out for assistance.
Pregnancy Use
When it comes to using Lip Medex Lip Balm during pregnancy, there is currently no available information 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’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best choices for your lip care during this time. Always prioritize your health and the health of your baby by seeking professional advice.
Lactation Use
If you are breastfeeding, you can use Lip Medex Lip Balm without any specific warnings or recommendations to worry about. There are no known concerns regarding its use during lactation (the period when you are nursing your baby) or any potential effects on breast milk. This means you can feel comfortable using this product while continuing to breastfeed.
Pediatric Use
If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.
Geriatric Use
While there is no specific information about the use of Lip Medex Lip Balm in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before using it, especially if you have any underlying health conditions or are taking other medications. This ensures that you can use the product safely and effectively.
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 is safe and effective, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual situation.
Hepatic Impairment
If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.
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 associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.
Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.
Storage and Handling
To ensure the best performance of your product, store it at room temperature and protect it from excessive heat. It's important to keep the container tightly closed when not in use to maintain its integrity. If you open the container and do not use the product for a prolonged period, please discard it to ensure safety and effectiveness. Following these guidelines will help you use 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 patient counseling.
FAQ
What is Blistex® Lip Medex®?
Blistex® Lip Medex® is a dermatologist-recommended lip protectant and external analgesic that provides instant moisturization and helps prevent future dryness.
What are the main uses of Blistex® Lip Medex®?
It is used for the temporary relief of pain and itching associated with minor lip irritation, and it helps protect and relieve chapped or cracked lips.
How should I apply Blistex® Lip Medex®?
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 should consult a doctor.
Are there any contraindications for using this product?
Do not use Blistex® Lip Medex® on deep or puncture wounds, animal bites, or serious burns.
What should I do if the condition worsens or symptoms last more than 7 days?
You should stop using the product and ask a doctor if your condition worsens or if symptoms last more than 7 days or clear up and occur again within a few days.
Is there any specific information regarding use during pregnancy or lactation?
There is no specific information regarding the use of Blistex® Lip Medex® during pregnancy or lactation in the provided drug insert.
What precautions should I take when using this product?
When using Blistex® Lip Medex®, do not get it into your eyes and do not apply it over large areas of the body or bandage.
How should I store Blistex® Lip Medex®?
Store it at room temperature, protect it from excessive heat, and keep the container tightly closed. Discard it after opening if not used for a prolonged period.
What should I do if the product is swallowed?
If swallowed, get medical help or contact a Poison Control Center right away.
Packaging Info
Below are the non-prescription pack sizes of Lip Medex Lip Balm (petrolatum, camphor (synthetic) , menthol, unspecified form, and phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Stick |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Stick |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Lip Medex Lip Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Blistex® Lip Medex® is a dermatologist-recommended lip protectant and external analgesic. This product is designed to deliver instant moisturization while helping to prevent future dryness. It provides a quick cooling effect and comfort for dry, sore lips. The product is available in a pack of three, with each stick containing a net weight of 0.15 oz. (4.25 g).
Uses and Indications
This drug is indicated for the temporary relief of pain and itching associated with minor lip irritation. It also temporarily protects and helps relieve chapped or cracked lips. Additionally, this drug aids in protecting the lips from the drying effects of wind and cold weather.
There are no teratogenic or nonteratogenic effects mentioned in the available data.
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 healthcare professional prior to use to determine the appropriate course of action.
Contraindications
Use of this product is contraindicated in the following situations:
Application is not recommended on deep or puncture wounds, animal bites, or serious burns due to the potential for exacerbating injury or delaying healing. Additionally, the product should not be applied to large areas of the body or covered with a bandage, as this may increase the risk of systemic absorption and adverse effects.
Contact with the eyes must be avoided to prevent irritation or injury.
Warnings and Precautions
This product is intended for external use only. It is contraindicated for application on deep or puncture wounds, animal bites, or serious burns. Healthcare professionals should advise patients to avoid contact with the eyes during use and to refrain from applying the product over large areas of the body or covering it with a bandage.
Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.
It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.
Side Effects
Patients should be aware that this product is for external use only. It is contraindicated for use on deep or puncture wounds, animal bites, and serious burns.
While using this product, patients are advised to avoid contact with the eyes and not to apply it over large areas of the body or bandage the treated area.
Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.
Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is recommended.
Drug Interactions
There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.
Packaging & NDC
Below are the non-prescription pack sizes of Lip Medex Lip Balm (petrolatum, camphor (synthetic) , menthol, unspecified form, and phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Stick |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Stick |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.
Geriatric Use
There is no specific information regarding the use of Lip Medex Lip Balm in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted studies or data in this population.
Pregnancy
There is currently no information available regarding the use of Lip Medex Lip Balm during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when recommending this product to pregnant patients, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. Women of childbearing potential should be advised to consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.
Lactation
There are no specific warnings or recommendations regarding the use of Lip Medex Lip Balm in lactating mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.
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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.
Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.
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 use of the compound in question.
Postmarketing Experience
No postmarketing experience details are available for SPL code 90375-7.
Patient Counseling
Advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct them that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.
Inform patients that this product should not be used on deep or puncture wounds, animal bites, or serious burns. It is important to counsel patients 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.
When using this product, patients should be cautioned to avoid contact with the eyes and to refrain from applying it over large areas of the body or covering it with a bandage.
Storage and Handling
The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat. The container must be kept tightly closed to maintain the integrity of the product. If the product is not used for a prolonged period after opening, it should be discarded to ensure safety and efficacy.
Additional Clinical Information
The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.
Drug Information (PDF)
This file contains official product information for Lip Medex Lip Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.