All Natural Eye Patch

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of the eyes.

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

Dosage and Administration

For adults and children aged 6 years and older, patches should be applied to the designated areas as illustrated in the accompanying diagram. Each patch must be removed after 8 hours of application.

In the case of children aged 2 to 6 years and adults with compromised health, the use of patches is advised only under the supervision of a healthcare professional.

Patches are contraindicated for use in children under 2 years of age; consultation with a doctor is required for this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds is prohibited due to the potential for adverse effects. The product should not be applied to irritated or damaged skin, as this may exacerbate the condition. If there is any change in the appearance of the product, it should not be used, as this may indicate instability or contamination. Additionally, individuals with hypersensitivity to this product must avoid its use to prevent allergic reactions. Finally, the product should only be used as directed; any deviation from the specified instructions is contraindicated.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes to prevent irritation or injury. Care should be taken to supervise the use of this product by children to ensure safety.

Caution is advised for individuals who are prone to allergic reactions, as this product may provoke such responses. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than seven days, symptoms resolve and then recur within a few days, excessive skin irritation develops, or if redness is observed. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then occur again within a few days, if excessive irritation of the skin develops, or if redness is present.

Additionally, patients should seek advice from a doctor or pharmacist before use if they are pregnant or taking other medications.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking other medications. This precaution is essential to identify potential drug interactions that may affect the efficacy or safety of treatment.

Monitoring and dosage adjustments may be necessary based on the specific medications being used concurrently. It is crucial for healthcare providers to evaluate the complete medication profile of the patient to ensure safe and effective use of this drug.

Packaging & NDC

Below are the non-prescription pack sizes of All Natural Eye Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be supervised during the use of this medication. For children aged 6 years and older, patches should be applied to the designated areas as illustrated in the accompanying diagram and removed after 8 hours.

In children aged 2 to 6 years and in adults with compromised health, the medication should only be used under the guidance of a healthcare professional. The use of this medication is not recommended for children under 2 years of age; consultation with a doctor is advised in such cases.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of this medication, particularly those who are prone to allergic reactions. Therefore, caution is advised when prescribing to this population.

In addition, geriatric patients with compromised health should only use this medication under the guidance of a healthcare provider. Close monitoring is recommended to ensure safety and efficacy in this demographic, as age-related physiological changes may influence drug metabolism and response.

Pregnancy

Pregnant patients are advised to consult a healthcare professional, such as a doctor or pharmacist, before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. Further clinical judgment should be applied based on individual circumstances.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to use the product on wounds, irritated, or damaged skin. Patients should be informed that the product should not be used if its appearance has changed or if they are hypersensitive to it.

Providers should emphasize that the product must be used only as directed. Patients should be instructed 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. Additionally, patients should be advised to discontinue use and seek medical advice if excessive skin irritation or redness occurs.

While using the product, patients should be cautioned to avoid contact with the eyes and mucous membranes. It is also essential to supervise children when they are using the product. Patients with a history of allergic reactions should be advised to use caution. Furthermore, healthcare providers should recommend that patients consult a doctor or pharmacist before using the product if they are pregnant or taking other medications.

Storage and Handling

The product is supplied in individual packages, which should be used immediately after opening to ensure optimal efficacy. It is essential to store the product in a dry area at temperatures below 35 ℃ (95 ℉) to maintain its stability and effectiveness. Proper handling and storage conditions are critical to preserving the integrity of the product.

Additional Clinical Information

The product is administered topically. For adults and children aged 6 years and older, patches should be applied to the designated areas as illustrated, and removed after 8 hours. In children aged 2 to 6 years and in adults with compromised health, use should only occur under the guidance of a healthcare professional. The product is not recommended for children under 2 years of age; consultation with a doctor is advised in such cases.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for All Natural Eye Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)