Aveeno Hydrocortisone Anti-Itch

Description

Aveeno® Anti-Itch Cream contains 1% hydrocortisone and is designed to provide effective relief from itching associated with various skin conditions, including eczema, psoriasis, and reactions to poison ivy, oak, and sumac, as well as insect bites and irritations from detergents and soaps. This maximum strength formula is specially formulated for longer-lasting relief and incorporates a blend of Triple Oat, aloe, and vitamin E. The product is dermatologist-recommended and is available in a net weight of 1 oz (28 g).

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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

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 adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

Use is contraindicated in patients with the following conditions or situations:

• Application in or near the eyes is contraindicated due to the potential for irritation or damage to ocular tissues.

• The product should not be used for diaper rash; consultation with a healthcare professional is advised in such cases.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied in or near the eyes. Additionally, the product should not be used for diaper rash; consultation with a healthcare professional is advised in such cases.

Healthcare professionals should advise patients to seek medical guidance prior to using this product if they are concurrently using any other hydrocortisone formulations.

Patients must be instructed to discontinue use and consult a physician if the condition worsens or if symptoms persist beyond 7 days. Furthermore, if symptoms resolve and then recur within a few days, it is essential to stop use and seek medical advice.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in or near the eyes and should not be applied for diaper rash unless directed by a healthcare professional.

Participants are advised to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

It is important for patients to consult a healthcare provider before using this product if they are currently using any other hydrocortisone product, as this may lead to increased risk of adverse reactions.

Drug Interactions

The concurrent use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult a healthcare professional prior to initiating treatment with hydrocortisone if they are currently using any other hydrocortisone formulations. This is to prevent potential additive effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Aveeno Hydrocortisone Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted for guidance.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for women who are pregnant. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for use in pregnant patients. It is advisable to monitor for any adverse effects and to counsel women of childbearing potential regarding the lack of available data.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the medication in or near the eyes, as this may lead to irritation or other complications. Additionally, it is important to inform patients that the product is not intended for use on diaper rash, and they should consult a doctor if they have questions regarding its use in such cases.

Healthcare providers should counsel patients to discontinue use and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. Patients should also be made aware that if their symptoms last longer than 7 days or if they improve and then recur within a few days, they should stop using the product and consult a healthcare professional.

Finally, patients should be encouraged to ask their doctor before using this medication if they are currently using any other hydrocortisone products, to avoid potential interactions or complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product in a manner that protects it from excessive heat, with a maximum temperature limit of 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

Clinicians should counsel patients about the potential for increased skin sensitivity to the sun due to the presence of alpha hydroxy acid (AHA) in the formulation. It is recommended that patients use sunscreen, wear protective clothing, and limit sun exposure while using the product and for one week following its use.

Drug Information (PDF)

This file contains official product information for Aveeno Hydrocortisone Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)