Bump and Bruise Reliever

Description

The product is identified by the SPL code 34089-3. No additional relevant information is available regarding its characteristics or specifications.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including conditions such as backache, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Additionally, it is important to refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and should not use this product in conjunction with heating pads or devices.

Patients must be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. For individuals who are pregnant or breastfeeding, it is advisable to seek guidance from a health professional before using this product.

This product should be kept 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.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Patients with sensitive skin are advised to consult a doctor before use.

While using this product, it is crucial to avoid contact with the eyes or mucous membranes and not to apply it to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and hands should be washed with cool water after use. Additionally, the product should not be used with heating pads or devices.

Patients are instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use.

It is also important to keep this product out of the reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance the absorption of the medication, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in the context of its application with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Bump and Bruise Reliever (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the product over affected areas up to four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is advised prior to use. It is important to keep the product out of the reach of children; in the event of accidental ingestion, medical assistance should be sought or a Poison Control Center contacted immediately.

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

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 evaluated in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 considered as part of standard clinical practice.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication 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 essential 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children. It is important to emphasize that if the medication is accidentally ingested, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently come into contact with the medication.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the lid is closed tightly to maintain the integrity of the product. Proper storage conditions are critical to preserving the quality and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 2 years and older, not exceeding four times daily. Massage of the area is not necessary. For children under 2 years of age, consultation with a physician is advised prior to 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 Bump and Bruise Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)