Radiaura Skin Recovery
Generic: LIDOCAINE HCL - HYDROCORTISONE ACETATE
Basic Information
Manufacturer
PureTek Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
c9502692-674d-e53f-e053-2a95a90a74b3
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.
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.
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 ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear.
Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion.
If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
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 ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear.
Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion.
If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
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.