Drugplain

Radiaura Skin Recovery 10 mg/g

Lidocaine HCl - Hydrocortisone Acetate · CREAM · PureTek Corporation

No Recall HistoryCurrently in Shortage
Plain English

Radiaura Skin Recovery is a cream containing lidocaine hcl - hydrocortisone acetate at 10 mg/g, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Radiaura Skin Recovery
Generic Name
Lidocaine HCl - Hydrocortisone Acetate
NDC Code (Product)
59088-432
Manufacturer
PureTek Corporation
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
09/02/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Apply product to the affected area(s) twice daily or as directed by a physician. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. Wash hands before and after application.

Warnings

WARNINGS: CONCERNS RELATED TO ADVERSE EFFECTS: Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (including pale, gray, or blue-colored skin (cyanosis), headache, rapid pulse, shortness of breath, lightheadedness, fatigue). WARNINGS: For external use only. Not for ophthalmic use. Keep out of reach of children. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle e

Contraindications

CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

ADVERSE REACTIONS: During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.

Frequently Asked Questions

What is Radiaura Skin Recovery used for?

Radiaura Skin Recovery contains Lidocaine HCl - Hydrocortisone Acetate. It is a cream taken topical. Consult your doctor for specific uses.

Is Radiaura Skin Recovery a controlled substance?

Radiaura Skin Recovery is not classified as a controlled substance by the DEA.

What is the generic name for Radiaura Skin Recovery?

The generic name for Radiaura Skin Recovery is Lidocaine HCl - Hydrocortisone Acetate. There are 1 other brand versions of Lidocaine HCl - Hydrocortisone Acetate.

What is the NDC code for Radiaura Skin Recovery 10 mg/g?

The NDC (National Drug Code) for Radiaura Skin Recovery 10 mg/g is 59088-432, listed by PureTek Corporation.

Product NDC

59088-432

Package NDC

59088-432-07

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)