Rugby Ice Blue

Description

Rugby® is an external analgesic formulated as a blue gel, designed for the relief of minor aches and pains associated with muscles and joints. The product is comparable to the active ingredient found in Mineral Ice®. Each container has a net weight of 8 ounces (226.8 grams).

Uses and Indications

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

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. It is important to note that the product is not recommended for use in children under 2 years of age; consultation with a healthcare professional is advised in such cases.

Contraindications

The product is contraindicated in the following situations:

• Co-administration with other topical pain relievers is not recommended due to the potential for increased irritation or adverse effects.

• Use with heating pads or other heating devices is contraindicated to avoid excessive heat and potential skin damage.

• Application in or near the eyes is contraindicated to prevent serious ocular irritation or injury.

• The product should not be applied to wounds or damaged skin, as this may lead to increased absorption and systemic effects.

• Tight bandaging of the application site is contraindicated to ensure proper circulation and prevent localized adverse reactions.

Warnings and Precautions

The product is intended for external use only. It is imperative that healthcare professionals advise patients against the concurrent use of other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of this product in conjunction with heating pads or other heating devices is contraindicated, as it may lead to excessive skin irritation or burns.

Care should be taken to avoid contact with the eyes; the product must not be applied in or near this area. Furthermore, it is essential to refrain from applying the product to wounds or damaged skin, as this could exacerbate irritation or delay healing. Bandaging should be done loosely, as tight bandages may restrict circulation and lead to further complications.

Patients should be instructed to 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. In addition, if any redness or irritation develops, it is crucial to stop use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Finally, 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 without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use with other topical pain relievers and should not be applied in conjunction with heating pads or other heating devices.

When using this product, patients are advised to avoid contact with the eyes and to refrain from applying it to wounds or damaged skin. Additionally, it is important not to bandage the area tightly after application.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The development of redness or irritation at the application site also warrants cessation of use and medical consultation.

Furthermore, it is recommended that pregnant or breastfeeding individuals seek advice from a healthcare professional prior to using this product. To ensure safety, the product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated. The combined use may increase the risk of adverse effects without providing additional therapeutic benefit.

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

It is advised to avoid these combinations to ensure patient safety and optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Rugby Ice Blue (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any 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 using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Healthcare professionals are advised to monitor for potential symptoms associated with overdosage, although specific symptoms are not detailed in the provided information. Prompt recognition and management of any adverse effects are crucial.

Management procedures may include supportive care and symptomatic treatment as necessary. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective intervention.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. 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 this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should be cautioned against using the product with heating pads or other heating devices, as this could lead to increased irritation or burns.

Healthcare providers should instruct 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. Patients should also be advised to discontinue use and seek medical advice if they experience any redness or irritation.

It is important to inform patients that they should avoid applying the product in or near the eyes, and they should not apply it to wounds or damaged skin. Furthermore, patients should be cautioned against tightly bandaging the area where the product is applied, as this may exacerbate irritation or other side effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature, specifically within the range of 20 to 25°C (68 to 77°F).

To ensure the integrity of the product, the lid must be kept tightly closed when not in use. Additionally, it is crucial to avoid using, pouring, spilling, or storing the product near heat sources or open flames to prevent any potential hazards. Proper adherence to these storage and handling guidelines will help maintain the product's quality and safety.

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 before use.

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 Rugby Ice Blue, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)