Cryo10 Topical Analgesic

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The product should be applied directly onto the affected area without the need for rubbing, massaging, or bandaging. It may be reapplied if necessary; however, it is important not to exceed four applications within a 24-hour period.

For adults and children over 12 years of age, it is recommended to consult a healthcare professional prior to use. For children under 12 years of age, it is essential to seek advice from a healthcare professional before application.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is advised not to bandage tightly or use a heating pad in conjunction with the product, as this may lead to increased risk of complications or discomfort.

Warnings and Precautions

Contact with the eyes should be strictly avoided, as it may lead to irritation or injury. This product is intended for external use only; any internal application is contraindicated. Additionally, the formulation is flammable; therefore, it must be kept away from fire or flame to prevent potential hazards.

It is imperative that this product is used only as directed. Users should refrain from tightly bandaging the area of application or using a heating pad, as these practices may exacerbate adverse effects. The product should not be applied to wounds or damaged skin, as this could lead to further complications.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than seven days, or if there is a recurrence of symptoms after initial improvement, particularly in the presence of redness. Furthermore, if excessive skin irritation develops, it is crucial to stop use and consult a healthcare provider.

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

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is crucial to avoid contact with the eyes, as this may lead to irritation or other complications. The product is intended for external use only, and users should exercise caution, as it is flammable; it must be kept away from fire or flame.

In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days accompanied by redness, medical advice should be sought. Patients should also discontinue use if excessive irritation of the skin develops, as this may indicate an adverse reaction requiring further evaluation.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cryo10 Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and younger should consult a healthcare professional for guidance regarding the use of this medication, as no specific dosing or instructions are provided for this age group. For patients over 12 years, it is recommended to seek medical advice before administration.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 drug 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 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 medication. 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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management of overdosage may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective management of any complications that may arise.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or apply a heating pad while using the medication, as this may lead to adverse effects. Additionally, patients should be instructed not to apply the medication to wounds or damaged skin to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that allows for easy application directly onto the affected area without the need for rubbing, massaging, or bandaging. It is essential to adhere to the recommended usage, which specifies that the product should not be applied more than four times daily.

Storage conditions require the product to be kept at room temperature. It is crucial to ensure that the product is stored away from fire or flame to prevent any hazards. Additionally, the product must be kept out of reach of children to ensure safety. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

The product is administered topically, with the application method involving rolling directly onto the affected area without the need for rubbing, massaging, or bandaging. Patients may repeat the application if necessary, but should not exceed four applications per day.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Cryo10 Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)