Lucky Supersoft

Description

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

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital itching.

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application in the genital area is not recommended for individuals with vaginal discharge; consultation with a healthcare professional is advised.

• The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is advised.

Additionally, the following precautions should be observed during use:

• Avoid contact with the eyes.

• Do not exceed the recommended dosage unless directed by a healthcare professional.

• The product should not be administered directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center without delay if the product is swallowed.

Healthcare providers should counsel patients to discontinue use and seek medical advice under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Additionally, patients should be advised to seek medical attention if rectal bleeding occurs, as this may indicate a more serious underlying condition.

Emergency medical help is crucial if the product is ingested. Prompt action is necessary to mitigate potential health risks associated with swallowing the product.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if the 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 seek medical attention if rectal bleeding occurs.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Lucky Supersoft (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional prior to use. For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. Additionally, it is advised that children under 12 years of age seek medical advice before using this product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this medication. Dosage adjustments may be necessary, and it is important for healthcare professionals to provide guidance tailored to the individual patient's needs. Hydrocortisone cream should only be used if clearly needed and under the supervision of a healthcare professional to ensure the safety of both the mother and the fetus.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to contact a poison control center or consult relevant clinical guidelines for further management strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, 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 product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have vaginal discharge and that they should consult a doctor for the treatment of diaper rash.

Patients should be instructed to discontinue use 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, they should be cautioned against using any other hydrocortisone product without first consulting a healthcare professional.

Patients must be made aware that they should stop using the product and seek medical advice if they experience rectal bleeding. While using the product, patients should be reminded to avoid contact with their eyes.

It is essential to communicate to patients that they should not exceed the recommended dosage unless directed by a doctor. Furthermore, they should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tube format. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to inspect the product prior to use; it must not be used if the tube seal under the cap is broken, missing, or if the tube tip is cut before opening. Proper handling is essential to ensure the integrity of the product.

Additional Clinical Information

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

Drug Information (PDF)

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

View product document (PDF)