Tiger Balm

Description

TIGER BALM® is a pain-relieving muscle spray indicated for the alleviation of muscle discomfort. The product is available in a net volume of 2.53 fluid ounces (75 mL) and is designed for easy application, particularly in hard-to-reach areas. The National Drug Code (NDC) for this formulation is 66761-327-75.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains, and sprains.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended administration involves spraying the product directly onto the affected area. This application should be repeated 3 to 4 times daily, as needed.

For children aged 12 years or younger, it is imperative to consult a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Prior to application, the product must be shaken well. The spray should be directed towards the area to be treated, maintaining a distance of approximately 6 inches from the skin. The formulation is designed for quick absorption; however, if desired, the area may be gently rubbed after spraying to enhance absorption.

Contraindications

The product is contraindicated in the following situations:

Application to wounds, damaged, or irritated skin is prohibited due to the potential for exacerbating the condition. Bandaging or covering the area with a wrap or heating pad is also contraindicated, as this may lead to increased irritation or adverse effects. Use is not recommended within one hour prior to bathing or within 30 minutes after bathing, as moisture may affect the product's efficacy. Additionally, the product should not be used in confined spaces, which may pose safety concerns.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals are advised to instruct patients to avoid contact with the eyes and mucous membranes. Application to wounds, damaged, or irritated skin is contraindicated.

It is imperative that the product is not bandaged, covered with a wrap, or used in conjunction with a heating pad. Patients should refrain from using the product within one hour prior to bathing or within 30 minutes after bathing to prevent adverse effects. Inhalation of the product should be avoided, and it should not be used in confined spaces. Additionally, the product must not be used near heat sources, flames, or while smoking.

Long-term storage should be maintained below 104°F (40°C), and the product should never be punctured or incinerated, as it is under pressure. Storage temperatures must not exceed 120°F (49°C) to ensure product integrity.

Patients should be advised to discontinue use and contact their healthcare provider if any of the following occur: worsening of the condition, severe skin irritation, persistent pain lasting more than seven days, or if pain resolves and then recurs after a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged, or irritated skin. Additionally, patients should refrain from bandaging or covering the treated area with a wrap or heating pad. The product should not be used within one hour prior to bathing or within 30 minutes after bathing, and inhalation should be avoided. It is also advised not to use the product in confined spaces.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, if severe skin irritation occurs, if pain persists for more than seven days, or if pain resolves and then recurs a few days later.

For those who are pregnant, breastfeeding, or have sensitive skin, it is recommended to seek advice from a healthcare professional before using this product.

Furthermore, this product should be kept out of 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.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult their healthcare provider prior to using this medication, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, it is always advisable for patients to inform their healthcare provider of all medications and supplements they are currently taking to ensure comprehensive care.

Packaging & NDC

Below are the non-prescription pack sizes of Tiger Balm (methyl salicylate, menthol, unspecified form, and camphor (synthetic)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 12 years of age may use the spray on the affected area, with a recommended frequency of 3 to 4 times daily. For children 12 years of age or younger, it is advised to consult a doctor prior to use.

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use, especially if they have sensitive skin. This precaution is essential to ensure the safety of both the mother and the fetus, as well as to address any potential risks associated with the use of this product during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication, especially if they are pregnant, breastfeeding, or have sensitive skin. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 drug. Consequently, there are no 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 event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to assess the situation thoroughly and initiate appropriate management procedures based on the specific circumstances and symptoms presented.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has indicated that this product may lead to allergic reactions in certain individuals. It is recommended that individuals with a known sensitivity to aspirin or salicylates conduct a patch test on a small area of skin prior to full application.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, severe skin irritation develops, pain persists for more than 7 days, or if pain resolves and then recurs after a few days.

When using this product, it is essential for patients to use it only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds, damaged, or irritated skin. Additionally, patients should not bandage or cover the area with a wrap or use a heating pad. It is important to inform patients to refrain from using the product 1 hour prior to bathing or within 30 minutes after bathing. Patients should also avoid inhalation of the product and should not use it in confined spaces.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

For adults and children over 12 years of age, the recommended administration involves spraying the product on the affected area 3 to 4 times daily. For children aged 12 years or younger, it is advised to consult a doctor prior to use.

Clinicians should inform patients of potential allergy risks; individuals with a history of allergic reactions to aspirin or salicylates should consult a doctor before using the product. Additionally, patients are advised to perform a patch test on a small area of skin prior to full application, as the product may cause allergic reactions in some individuals.

Drug Information (PDF)

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

View product document (PDF)