Burn

Description

Burn Spray is a pain-relieving formulation specifically designed for the treatment of minor burns. The product is available in a 3 fluid ounce (88.7 mL) dosage form. It is classified as a first aid product and is distributed by First Aid Only, Inc., located in Vancouver, WA 96882, USA.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. It is formulated as a pain-relieving spray specifically designed for application on minor burn injuries.

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

Dosage and Administration

Adults and children aged 2 years and older should apply an even layer of the burn spray to the affected area, not exceeding 3 to 4 applications per day. 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 the following situations:

• Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for increased irritation or adverse effects.

• Avoid application near the eyes; in the event of contact, rinse thoroughly with water to prevent irritation or injury.

Warnings and Precautions

For external use only. It is imperative that the product is not applied in large quantities, especially over raw or blistered areas, as this may exacerbate irritation or lead to adverse effects. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water to mitigate potential harm.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or if symptoms resolve and then return. This precaution is essential to ensure that any underlying issues are appropriately addressed.

Additionally, it is crucial to keep this product out of the reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay to ensure proper management of the situation.

Side Effects

For external use only. Patients are advised not to use the product in large quantities, particularly over raw or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, it is recommended to rinse thoroughly with water.

Patients should discontinue use and consult a healthcare professional if their condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

It is important to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable to continue standard clinical practices and monitor for any potential interactions as new data becomes available.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to spray an even layer of burn spray over the affected area, not to exceed 3-4 applications daily.

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

The safety of BURN - lidocaine hydrochloride spray during pregnancy has not been established, as no specific information regarding its use in pregnant patients is provided in the drug insert. There are no contraindications noted for use during pregnancy, nor are there any associated risks to the fetus documented. Additionally, the prescribing information does not indicate any required dosage modifications or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

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 and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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

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 light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity.

To maintain optimal conditions, the container must be kept upright at all times. Additionally, once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of an even layer of burn spray over the affected area for adults and children aged 2 years and older, not exceeding 3-4 times daily. For children under 2 years of age, consultation with a physician is advised. 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 Burn, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)