Allg Essentials Pain Relief

Description

ALL G® ESSENTIALS Extra Strength Pain Relief is a fast-acting pain roller formulated with broad spectrum CBD. Each 3 fl oz (88 ml) container contains 150 mg of CBD, designed to provide a fast, calming, and pain-relieving experience. This product is suitable for addressing various conditions, including injury, aches, pain, arthritis, and relaxation. It is also paraben-free, ensuring a more natural formulation.

Uses and Indications

This drug is indicated for the temporary relief of muscle and joint pain associated with arthritis. It is also effective in alleviating muscle aches, muscle strains, and general joint pain.

Limitations of Use This drug is intended for short-term use and should not be used as a substitute for comprehensive treatment of underlying conditions.

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as directed. It is contraindicated for use in children under 12 years of age.

For application, the medication should be rolled onto the affected area, with a maximum frequency of four times daily. Prior to each use, it is essential to shake the container well to ensure proper mixing of the formulation.

Contraindications

The product is contraindicated for use on wounds or irritated skin due to the potential for exacerbating the condition. Additionally, it should not be used with tight bandaging or in conjunction with a heating pad, as this may lead to adverse effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or are currently taking any anticoagulants.

When utilizing this product, it is imperative to avoid application on wounds or irritated skin. Patients should be instructed not to bandage the area tightly or use it in conjunction with a heating pad. Additionally, it is recommended that patients wash their hands thoroughly with cool water after application to prevent unintended contact with sensitive areas.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is advised before use to ensure safety for both the mother and child.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or poison control center.

Patients should be advised to discontinue use and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to reoccur within a few days. Regular monitoring of the patient's condition is recommended to ensure appropriate management and response to treatment.

Side Effects

Patients should be aware of several important warnings and adverse reactions associated with the use of this product. It is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

Before using this product, patients are advised to consult a doctor if they have sensitive skin or are taking any blood thinners. During use, it is crucial not to apply the product on wounds or irritated skin. Additionally, patients should avoid bandaging the area tightly or using it in conjunction with a heating pad. After application, hands should be washed thoroughly with cool water.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. This product should be kept out of reach of children. In the event of accidental ingestion, patients should contact a doctor or poison control center immediately.

Patients are instructed to discontinue use and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if the condition clears up only to reoccur within a few days.

Drug Interactions

Patients taking blood thinners should consult a healthcare professional prior to using this medication. The interaction between this drug and anticoagulants may increase the risk of bleeding. Monitoring of coagulation parameters may be necessary to ensure patient safety and to adjust dosages accordingly.

Packaging & NDC

Below are the non-prescription pack sizes of Allg Essentials Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. It is important to note that the use of this medication is contraindicated in children under 12 years of age.

Healthcare providers should exercise caution when administering this medication to geriatric patients, as age-related physiological changes may affect drug metabolism and response. Monitoring for efficacy and adverse effects is recommended, particularly in this population.

Dosage adjustments may be necessary based on individual patient factors, including renal and hepatic function, which can be more variable in elderly patients. Regular assessment and close monitoring are advised to ensure optimal therapeutic outcomes while minimizing potential risks.

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 breastfeeding infants are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, it is imperative to keep the product out of reach of children. Should accidental ingestion occur, immediate action is required. Healthcare professionals should advise caregivers to contact a physician or a poison control center without delay.

Prompt medical evaluation is essential to assess the situation and determine the appropriate course of action. Symptoms of overdosage may vary depending on the specific substance involved, and healthcare providers should be prepared to manage any potential adverse effects that may arise.

In summary, vigilance in preventing access to the product by children and swift communication with medical professionals in the case of accidental ingestion are critical components of effective overdosage management.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is accidentally swallowed, they should contact a doctor or poison control center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if the condition clears up and then reoccurs within a few days.

When discussing the proper use of the product, healthcare providers should emphasize that it should not be applied to wounds or irritated skin. Patients should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Additionally, it is important to instruct patients to wash their hands with cool water after using the product.

Healthcare providers should also recommend that patients consult a doctor before using the product if they have sensitive skin or are currently taking any blood thinners.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to keep the cap tightly closed to maintain the integrity of the product. Proper storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommended application of no more than four times daily to the affected area. Clinicians should advise patients that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames. Patients are cautioned to consult a doctor prior to use if they have sensitive skin or are taking blood thinners.

When using the product, it should not be applied to wounds or irritated skin, and patients should avoid tight bandaging or the use of heating pads. It is important for patients to wash their hands with cool water after application. Pregnant or breastfeeding individuals should seek advice from a health professional before use. The product should be kept out of reach of children, and in the event of accidental ingestion, a doctor or poison control center should be contacted immediately. Patients are advised to discontinue use and consult a doctor if their condition worsens, if pain persists for more than seven days, or if symptoms resolve and then recur within a few days.

Drug Information (PDF)

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

View product document (PDF)