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White Flower Analgesic Balm Floral Scented

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Camphor (synthetic) 5.4 g/100 mL
  • Menthol 13.0 g/100 mL
  • Methyl Salicylate 35.8 g/100 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
July 30, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 5.4 g/100 mL
  • Menthol 13.0 g/100 mL
  • Methyl Salicylate 35.8 g/100 mL
Other brand names
Dosage form
Oil
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 2010
Label revision date
July 30, 2010
Manufacturer
JELMA PHILIPPINES INC
Registration number
part348
NDC root
51681-0011
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED is a topical product designed to provide relief from minor aches and pains. This balm is infused with a floral scent, making it pleasant to use while targeting discomfort in muscles and joints.

You can apply this balm directly to the affected area for soothing relief. Its formulation is intended to help you feel more comfortable and relaxed, making it a convenient option for managing everyday aches.

Uses

This drug is used as an analgesic balm, which means it helps relieve pain when applied to the skin. It can be beneficial for soothing discomfort in various areas of your body.

There are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects associated with this drug. This makes it a potentially safe option for pain relief, but it's always best to consult with a healthcare professional for personalized advice.

Dosage and Administration

If you are an adult or a child aged 3 years and older, you can apply one to two drops of the medication directly to the affected area. It’s important to do this no more than 3 to 4 times a day. After applying the drops, gently massage the area to help the medication absorb better.

If you are under 3 years old or pregnant, you should not use this medication without first consulting a physician (doctor). Always make sure to follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely to avoid any complications. You should never apply it to irritated or damaged skin, or on any wounds. Always follow the directions provided and avoid using it in any way that is not specified. Additionally, keep it away from your eyes and mucous membranes, and do not apply a tight bandage over the area.

By adhering to these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about how to use this product, please consult with a healthcare professional.

Side Effects

If you experience any of the following while using this medication, it's important to stop use 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. You should also seek medical advice if you notice excessive skin irritation, or if you develop nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

For those using this medication for arthritis pain, contact your doctor if the pain continues for more than 10 days, if you see any redness, or if the treatment is for a child under 12 years of age.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental poisoning. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

When using this product, avoid applying it to irritated or damaged skin, and do not use it on wounds. Always follow the directions provided. If you notice that your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, seek medical advice if you experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. For those using it for arthritis pain, stop use if pain persists for more than 10 days, if you see redness, or if it’s being used for children under 12 years of age.

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, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or have a child under 3 years old, it is important to consult your physician before using this medication. Your healthcare provider can help you understand the potential risks and benefits, ensuring the safety of both you and your baby. Always prioritize professional guidance when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using any medication. The safety of this medication during lactation (the period of breastfeeding) has not been established, and it is unclear whether it can be passed into breast milk. Your healthcare provider can help you weigh the potential risks and benefits to ensure the well-being of both you and your baby.

Pediatric Use

If you are considering using this medication for your child, it's important to know that it should not be used in children under 3 years of age or in pregnant women without consulting a physician. For children aged 3 years and older, you can apply one to two drops to the affected area, but make sure to do this no more than 3 to 4 times a day and massage it gently into the skin.

Be cautious if your child is under 12 years old, as using the medication incorrectly can be dangerous. Always keep the product out of reach of children to prevent accidental poisoning. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

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 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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 priority, and your healthcare provider is there to help you navigate your treatment plan.

Storage and Handling

To ensure the safety and effectiveness of your product, always keep it tightly sealed when not in use. Store it in a cool, dry place at or below 30º C (86º F) and away from direct sunlight. This will help maintain its quality and prevent any degradation.

When handling the product, be sure to follow these storage guidelines closely. Proper storage not only protects the product but also ensures that it functions as intended when you need it.

Additional Information

You should apply one to two drops of the medication to the affected area, not more than three to four times a day. Gently massage the area after application. This medication is suitable for adults and children aged three years and older. However, if you are under three years old or pregnant, you should not use this product and should consult a physician instead.

It's important to keep this medication out of reach of children to prevent accidental poisoning. If the medication is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is WHITE FLOWER ANALGESIC BALM used for?

WHITE FLOWER ANALGESIC BALM is used as an analgesic balm to relieve pain.

Who should not use this balm?

Children under 3 years of age and pregnant women should not use this balm without consulting a physician.

How should I apply the balm?

For adults and children 3 years and older, apply one to two drops to the affected area up to 3 to 4 times daily and massage gently.

What precautions should I take when using this balm?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and do not use on irritated or damaged skin or wounds.

What should I do if I experience side effects?

Stop use and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience excessive skin irritation or other serious symptoms.

What should I do if the balm is swallowed?

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

How should I store the balm?

Store the balm tightly sealed at or below 30º C (86º F), away from direct sunlight.

Is it safe to use this balm while breastfeeding?

Consult a physician before use, as safety during lactation has not been established.

Packaging Info

Below are the non-prescription pack sizes of White Flower Analgesic Balm Floral Scented (camphor, menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for White Flower Analgesic Balm Floral Scented.
Details

Drug Information (PDF)

This file contains official product information for White Flower Analgesic Balm Floral Scented, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The White Flower Analgesic Balm is a topical formulation with a floral scent, packaged in a 0.338 fluid ounce (10 mL) container. The product is identified by the National Drug Code (NDC) 51681-0011-1.

Uses and Indications

This drug is indicated for use as an analgesic balm.

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

Dosage and Administration

For adults and children aged 3 years and older, the recommended dosage is one to two drops applied to the affected area, not exceeding 3 to 4 applications per day. It is advised to massage the area gently after application to enhance absorption.

Use of this product is contraindicated in children under 3 years of age and in pregnant women. In such cases, consultation with a physician is strongly recommended prior to use.

Contraindications

Use is contraindicated in the following situations:

Application on irritated or damaged skin is prohibited due to the potential for exacerbating the condition. The product should not be applied to wounds, as this may impede healing and increase the risk of infection. Additionally, use must adhere strictly to the provided directions; deviations from these instructions are contraindicated.

Contact with the eyes or mucous membranes should be avoided to prevent irritation or adverse reactions. Furthermore, tight bandaging of the area where the product is applied is not recommended, as it may lead to complications.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

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

General Precautions The product should not be applied to irritated or damaged skin, nor should it be used on open wounds. It is essential to use this product strictly as directed to avoid adverse effects.

Emergency Medical Help If the product is swallowed, it is crucial to obtain medical help or contact a Poison Control Center immediately.

Discontinuation and Consultation Users should discontinue use and consult a healthcare professional if any of the following occur:

  • The condition worsens.

  • Symptoms persist for more than 7 days.

  • Symptoms resolve and then recur within a few days.

  • There is excessive skin irritation.

  • Symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash develop.

  • When used for arthritis pain, if pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

Side Effects

Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, excessive skin irritation develops, or gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest.

In the context of using the product for arthritis-related pain, patients are advised to seek medical attention if pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

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 White Flower Analgesic Balm Floral Scented (camphor, menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for White Flower Analgesic Balm Floral Scented.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product and must consult a physician prior to use. For children aged 3 years and older, the recommended dosage is one to two drops applied to the affected area, not exceeding 3 to 4 times daily, with gentle massage.

In conditions affecting children under 12 years of age, it is crucial to adhere to the aforementioned warnings, as improper use may pose significant risks. Additionally, this product should be kept out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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 women are advised against the use of this medication and should consult a physician for alternative options. The safety of this medication during pregnancy has not been established, and potential risks to fetal outcomes are not well characterized. Therefore, healthcare professionals should exercise caution and consider the potential benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. The safety of this medication during lactation has not been established, and the potential for excretion in breast milk is currently unknown. Therefore, healthcare professionals should exercise caution when considering this medication for nursing mothers.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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, 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 to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

Children under 3 years of age and pregnant women should not use this product; consultation with a physician is advised. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Reports of serious side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events associated with the use of the product. For reporting purposes, a dedicated phone number is available to facilitate the communication of these serious side effects.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. 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 on irritated or damaged skin, or on wounds. It is essential to emphasize that the product should only be used as directed.

Patients should be counseled 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. They should also be advised to discontinue use and seek medical advice if they experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

For those using the product for arthritis pain, patients should be instructed to stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the patient is a child under 12 years of age.

Additionally, patients should be cautioned to avoid contact with the eyes or mucous membranes while using the product and to refrain from bandaging the area tightly.

Storage and Handling

The product is supplied in a tightly sealed container to ensure its integrity. It should be stored at or below 30º C (86º F) and kept away from direct sunlight to maintain its efficacy. Proper handling and storage conditions are essential to preserve the quality of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of one to two drops to the affected area for adults and children aged 3 years and older, not exceeding 3 to 4 times daily. It is advised to massage the area gently after application. For children under 3 years of age and pregnant women, consultation with a physician is necessary before use.

Clinicians should counsel patients to keep the product out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for White Flower Analgesic Balm Floral Scented, 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 White Flower Analgesic Balm Floral Scented, 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.

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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.