Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Fo...

Description

The product is a topical balm formulated with natural ingredients. It contains active components such as aloe vera and vitamin E, which are intended to soothe and moisturize the skin. The balm is packaged in a 2 oz (56.7 g) jar. Inactive ingredients include beeswax, coconut oil, and essential oils.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively clears acne blemishes and facilitates the healing of the skin. Additionally, it helps prevent the development of new acne blemishes. There are no teratogenic or nonteratogenic effects mentioned associated with this drug.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This should be done one to three times daily, depending on the patient's needs and the physician's guidance.

To minimize the risk of excessive drying of the skin, it is advisable to initiate treatment with one application per day. Based on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily as necessary.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once daily or every other day. Adjustments should be made based on individual patient response and clinical judgment.

Contraindications

The use of this product is contraindicated in patients who are concurrently using another topical acne medication, as this may increase the risk of skin irritation and dryness. In the event of irritation, it is advised to limit the use to one topical acne medication at a time.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Skin irritation and dryness may occur, particularly when this product is used concurrently with other topical acne medications. To minimize the risk of adverse effects, it is recommended that only one topical acne treatment be utilized at a time. If irritation develops, discontinue use of all topical acne medications and consult a healthcare professional for further guidance.

Healthcare professionals should monitor patients for signs of skin irritation and dryness, advising them to report any adverse reactions promptly.

Side Effects

Patients should be advised that the product is for external use only. There are no specific adverse reactions or side effects reported in clinical trials or postmarketing experiences beyond this warning. It is important for patients to adhere strictly to the intended use to avoid any potential complications.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of additional topical agents is recommended to allow the skin to recover. Monitoring for signs of irritation is essential to ensure patient comfort and treatment adherence.

Packaging & NDC

Below are the non-prescription pack sizes of Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should discuss any plans for pregnancy with their healthcare provider.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 medication is swallowed. It is crucial for patients to understand the potential risks associated with accidental ingestion.

Additionally, healthcare providers should inform patients about the likelihood of skin irritation and dryness when using this medication in conjunction with other topical acne treatments. Patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation. This guidance will help ensure safe and effective use of the medication while reducing the potential for adverse skin reactions.

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 a temperature range of 15° to 30° C (59° to 86° F). Care should be taken to keep the product away from direct sunlight to maintain its integrity and effectiveness.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)