Dollar General Cold Therapy Pain Relief

Description

Dollar General Cold Therapy Pain Relief is a topical analgesic designed to provide temporary relief from minor aches and pains. The formulation is intended for external use and is characterized by its cold therapy properties. The product is packaged for convenience and ease of application, ensuring effective delivery of its active ingredients. The effective date of this formulation is August 28, 2023.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children 12 years of age and over should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. The application may be repeated as necessary, but should not exceed three patches in a 24-hour period. After use, the patch must be discarded, and the pouch should be resealed to maintain integrity.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Infants should not be treated with this product due to the potential for adverse effects.

Additionally, the product should not be applied in the following circumstances:

• Do not bandage tightly or use in conjunction with a heating pad, as this may increase the risk of skin irritation or burns.

• Avoid contact with eyes and mucous membranes to prevent irritation or injury.

• Do not apply to wounds or damaged skin, as this may exacerbate the condition or lead to systemic absorption.

• Concurrent use with other topical analgesics is contraindicated to avoid potential additive effects and increased risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid tight bandaging or the simultaneous use of heating pads while using this product. Contact with eyes and mucous membranes should be strictly avoided, and it should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is contraindicated.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of serious burns have been reported with products of this type. It is important to avoid bandaging tightly or using the product in conjunction with a heating pad. Additionally, contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Concurrent use with other topical analgesics is not recommended.

Patients are advised to stop use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant discontinuation of use and medical consultation.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimize treatment efficacy. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Dollar General Cold Therapy Pain Relief (menthol 5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if they are infants. For children under 12 years of age, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8 hours, with the option to repeat the application as necessary, not exceeding three times daily. After each use, the patch should be discarded, and the pouch resealed to maintain integrity.

It is essential to keep this product out of reach of children to prevent accidental exposure.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health 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 drug insert 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use on infants. In the event of accidental ingestion, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is essential for patients to use the product only as directed. Providers should inform patients that there have been rare reports of serious burns associated with similar products. Patients should be cautioned against tightly bandaging the area where the product is applied or using it in conjunction with a heating pad.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, as well as not applying the product to wounds or damaged skin. Furthermore, patients should be advised not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dollar General Cold Therapy Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)